Optetrak 200-64-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862041104), received between Jul 9, 2021 and Sep 3, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K932690); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0019-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2024Naturally Worn; Naturally Worn

  "LEGAL CASE ¿ USA (MDL NO. (B)(4)) PATIENT ID: + RIGHT KNEE IT WAS REPORTED THAT APPROXIMATELY 137 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, OSTEOLYSIS, PAIN, SYNOVIAL, EFFUSION AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Rheumatoid Arthritis; Synovitis

  MAUDE report 20125073 ↗
• InjuryJun 15, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6)2008. THEY HAD LEFT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 15 YEARS AFTER THEIR INITIAL IMPLANTATION. PREOPERATIVELY THERE WERE SIGNS OF SOME OSTEOLYSIS AROUND THE IMPLANT BUT NO CLEAR SIGN THAT THE IMPLANT WAS LOOSE. HOWEVER, THERE WAS SIGNIFICANT NARROWING ON THE MEDIAL SIDE OF THE IMPLANT SUGGESTING EXCESSIVE POLYETHYLENE WEAR. POSTOPERATIVE DIAGNOSIS: POLYETHYLENE WEAR OF LEFT TOTAL KNEE REPLACEMENT WITH ASEPTIC TIBIAL LOOSENING. PATELLA COMPONENT SHOWED SOME WEAR BUT WAS NOT EXTENSIVE. THE PATELLA BUTTON SEEMED TO BE WELL FIXED AND WAS LEFT AS IS. THE POLYETHYLENE HAD WORN THROUGH COMPLETELY IN THE POSTERIOR MEDIAL CORNER AND HAD DISRUPTED THE LOCKING MECHANISM ON THE POLYETHYLENE. THE FEMORAL COMPONENT APPEARED TO BE FIXED, BUT THE TIBIAL COMPONENT WAS LOOSE, AS IT HAD SOME MOTION. THERE WAS MOTION UNDERNEATH THE TRAY AND FLUID MOVING IN AND OUT ON THE MEDIAL SIDE. THERE WAS A LITTLE BIT OF A OSTEOLYTIC CYST ON THE LEFT MEDIAL FEMORAL CONDYLE BUT WAS CONTAINED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OT

  Patient problems: Cyst(s); Failure of Implant; Osteolysis

  MAUDE report 17136506 ↗
• InjuryMay 24, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL (B)(6), REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN INPERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. THIS PATIENT (B)(6) WAS IMPLANTED WITH A 200-64-09-INSERTO TIBIAL SLOPE+ CR 4-9 MM, SERIAL NUMBER (B)(6) ON (B)(6) 2014. THE INSERT WAS MANUFACTURED ON 8/3/2010 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 8/3/2010 AND WAS 3 YEARS 5 MONTHS SHELF AGE AT THE TIME OF IMPLANT. ON 0/0/21, APPROXIMATELY 7.0 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 16998955 ↗
• InjuryDec 12, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THIS 61 YEAR OLD MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2014. THE PATIENT WAS REVISED DUE TO POLY WEAR. THERE IS NO REPORTED BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15963695 ↗
• InjuryJul 14, 2021Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT PRESENTED WITH PAIN AND INSTABILITY. THE SURGEON NOTED THERE WAS SEVERE DAMAGE TO THE POLY AND THERE WERE NOTICEABLE DAMAGE ON THE TIBIAL TRAY. THE SURGEON HAD TO REVISE THIS TO A HINGE KNEE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 12170656 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 7.5 YRS POSTOP THE INITIAL IMPLANT, THE MALE PATIENT WAS REVISED FOUND CATASTROPHIC POLY FAILURE WITH MASSIVE OSTEOLYSIS OF THE RIGHT KNEE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Osteolysis

  MAUDE report 12143668 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932690. One submission often covers many models, so check the product and lot details in each record.

• Z-2156-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
• Z-2155-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
• Z-2157-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
• Z-2158-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
• Z-0582-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-