The Food and Drug Administration (FDA) has issued a warning letter to Orchid Orthopedic Solutions LLC, citing both manufacturing defects and possible sources of infection in its processes for adding bone-ingrowth-stimulating coatings to orthopedic implants.
Orchid, majority-owned by European private equity firm Nordic Capital Fund IX, manufactures its own implants and instruments at facilities around the U.S. and in Europe, and provides surface coatings for other implant manufacturers. The FDA letter is aimed at only Orchid’s Farmington Hills, Michigan, plant, which does coatings for implants. FDA inspectors visited the plant February 4-15, 2019.
The lengthy letter says the FDA considers the company’s March 11, 2019 response to the initial FDA “FDA-483, List of Inspectional Observations” inadequate on several matters. However, it contains so many redactions for supposedly trade-secret content—36 in all, some of which seem to be FDA bending over backwards for Orchid’s benefit—that in some places, it’s difficult to be sure what the FDA is targeting. For example:
When implant coatings are deemed defective at the plant, the company reworks them to bring them up to standards. A rework requires a corresponding “non-compliance report,” or NCR. The FDA letter says the documentation of the reworks is inadequate in numerous ways, such as:
“For example, between March 10, 2016 and February 4, 2019 there were (redacted) Rework Shop Orders, yet only (redacted) NCRs for nonconformances, such as chipped coating, scratches, debris, etc.”
The withheld information makes it next to impossible to tell whether this is significant or merely a minor record-keeping matter.
Cleaning water left unsterilized?
Similarly, the FDA letter makes it difficult to determine the seriousness (or lack thereof) of bacterial contamination issues. The letter says:
“Your procedures for monitoring the quality of (redacted) water used in the device cleaning process (WI-6.4.2ENG-01: (redacted) Water Testing) and procedures for monitoring the device cleaning process (WI-7.5PRD-95: (redacted) Cleanline Monitoring) are inadequate and/or unfollowed. For example:
“Procedure WI-6.4.2ENG-01 requires sanitization of the (redacted) water system in the event of bacterial endotoxin excursion ((redacted) EU/mL); there were (redacted) excursions between July 2, 2018 and January 31, 2019, yet the water system was only sanitized (redacted) times.”
That appears to say that bacteria got into the cleaning water for something on some unstated (but known) number of times, but the water system wasn’t sanitized every time bacteria were detected in the water used to clean medical implants.
Similarly:
- “Procedure WI-6.4.2ENG-01 requires (redacted) testing for Total Organic Carbon (TOC); testing was not performed in December 2018.”
- “Procedure WI-6.4.2ENG-01 requires an increase of bioburden or TOC testing from (redacted) to (redacted) in the event of an excursion yet testing remained (redacted) despite bioburden test results being “too numerous to count” in September 2018 and a TOC excursion of (redacted) mg/L for November 2018.”
The phrase, “too numerous to count” might (or might not) indicate a serious bacterial contamination issue. However, the FDA letter leaves Orchid’s business partners, and even more, surgeons who use the affected implants, in the dark.
Numerous other deficiencies are cited in the FDA letter, which also says, ominously:
“Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”
Also, the FDA letter threatens to notify other federal agencies which might award contracts, hold up requests for certification of devices to foreign governments, and withhold premarket approvals for Class III devices until the issues are remedied.
The FDA letter gives the company 15 days from May 13 to reply with a compliance schedule.
We contacted Orchid Orthopedic Solutions for comments on the FDA action and the former employee comments but received no response by deadline.
What is done at this plant?
“As a leader in coating technology, Orchid has coated more than 2.5 million implants. Orchid offers a wide variety of advanced technology coatings and surface treatments to meet the challenge of implant fixation,” the web page for the Farmington Hills coatings operation says. Specifics:
“Coating Capabilities:
- Thick HA Coating at 150 microns
- TPS/VPS orthopedic coating on titanium or CoCr substrates that enables the coating to exceed the ASTM requirement
- RBM surface treatment on titanium substrates creating a roughened surface comparable to a 100 mesh Al2O3 finish without leaving any embedded debris
- Composite coatings including HA on plasma, beads, irregular sintered coatings and TPS on RBM-prepared substrates
- Porous coatings such as spherical bead, asymmetrical powder and irregular particle coatings, available in a range of powder sizes, types and coating processes to meet tight tolerances or unusual specifications
- Rough porous TPS coating with higher roughness and greater porosity (>100 micron pore size in all zones) of this coating meets the ASTM standard for porous coating
- Proprietary Coatings
- Custom coating technologies: customer-driven solutions including traditional bead coatings and more novel applications such as porous metal foam
- Proprietary HA coating on titanium, cobalt-chromium or stainless steel
- Proprietary titanium coating on PEEK utilizing a special process to protect the mechanical properties of the PEEK substrate
- Osseomatrix® titanium foam
- Asymmatrix®: Material flexibility with significantly greater porosity than spherical beads”
Orchid also produces sterile packaging at that site; the FDA letter, to the extent it could be understood with all the redactions, seems to have focused only on the coatings operation.
We were unable to determine which manufacturers use Orchid’s coatings for their implants.
