Optetrak 200-62-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862041029), received between Nov 5, 2019 and Jun 25, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Naturally Worn” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK CLASSIC DEVICE ON THE RIGHT KNEE AND THEN APPROXIMATELY 7 YEARS LATER THE PATIENT WAS REVISED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19610387 ↗
• InjuryJun 24, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YEARS AND 9 MONTHS POST THE INITIAL LEFT TKA, THE PATIENT WAS REVISED DUE TO POLY WEAR. EVERYTHING WAS REMOVED. THERE WAS NO REPORTED BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19594228 ↗
• InjuryNov 29, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2013. 10 YEARS LATER THE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN. THE SURGEON DIAGNOSED WEAR OF THE TIBIAL INSERT AND A REVISION WAS PERFORMED ON AN UNKNOWN DATE. BREAKAGE AND WEAR WAS OBSERVED IN THE RETRIEVED TIBIAL INSERT. NO METALLOSIS WAS FOUND. NO PROBLEM OF THE LOCKING MECHANISM OF THE TIBIAL TRAY WAS FOUND. ALL PROLIFERATIVE TISSUE WAS REMOVED. PARTS AND PIECES FELL INTO THE PATIENT WOUND SITE AND WERE REMOVED BY THE SURGEON. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Implant Pain; Swelling/ Edema

  MAUDE report 18235131 ↗
• InjuryOct 26, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2010. APPROXIMATELY 12 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON 24 JAN 2023. DIAGNOSIS: FAILED RIGHT KNEE. THERE WAS INSTABILITY, LOOSENING AND DEBONDING. FEMORAL AND TIBIAL COMPONENTS WERE EASILY REMOVED. PATELLA COMPONENT HAD MILD TO MODERATE WEAR. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant; Joint Laxity; Pain; Synovitis

  MAUDE report 18010581 ↗
• InjurySep 5, 2023Naturally Worn; Naturally Worn

  AS REPORTED, AFTER ABOUT SIX YEARS LATER FROM A PRIMARY SURGERY, THE 80 Y/O MALE PATIENT WHO HAD TOTAL KNEE ARTHROPLASTY USING CR SLOPE + TIBIAL INSERTS COMPLAINED KNEE SWELLING AND PAIN, THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERTS, THEN REVISION SURGERY FOR THE REPLACEMENT OF THE TIBIAL INSERTS FOR BOTH SIDE WERE PERFORMED. SURGEON DECIDED THAT ALL EXACTECH¿S COMPONENT WAS REMOVED AND COMPETITOR¿S REVISION DEVICE WAS IMPLANTED FOR BOTH SIDE. POLYETHYLENE PARTICLES AND PROLIFERATIVE (GROWTH) TISSUES ON THE SURGICAL FIELD WERE RESECTED BY THE SURGEON APPROPRIATELY. THERE WAS NO NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN IMAGES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. . ,

  Patient problems: Failure of Implant; Implant Pain; Osteolysis; Swelling/ Edema

  MAUDE report 17686553 ↗
• InjurySep 5, 2023Naturally Worn; Naturally Worn

  AS REPORTED, AFTER ABOUT SIX YEARS LATER FROM A PRIMARY SURGERY, THE 80 Y/O MALE PATIENT WHO HAD TOTAL KNEE ARTHROPLASTY USING CR SLOPE + TIBIAL INSERTS COMPLAINED KNEE SWELLING AND PAIN, THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERTS, THEN REVISION SURGERY FOR THE REPLACEMENT OF THE TIBIAL INSERTS FOR BOTH SIDE WERE PERFORMED. SURGEON DECIDED THAT ALL EXACTECH¿S COMPONENT WAS REMOVED AND COMPETITOR¿S REVISION DEVICE WAS IMPLANTED FOR BOTH SIDE. POLYETHYLENE PARTICLES AND PROLIFERATIVE (GROWTH) TISSUES ON THE SURGICAL FIELD WERE RESECTED BY THE SURGEON APPROPRIATELY. THERE WAS NO SURGICAL DELAY / PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN IMAGES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Implant Pain; Swelling/ Edema

  MAUDE report 17686435 ↗
• InjuryJun 5, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  REVISION OPERATIVE REPORT ON (B)(6) 2016- POSTOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING WITH POLYETHYLENE WEAR OF A RIGHT TOTAL KNEE ARTHROPLASTY. RIGHT KNEE REVISION OF ALL COMPONENTS. PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. IT APPEARED AS THOUGH THE POLYETHYLENE HAD FULLY BEEN WORN THROUGH IN THE POSTERIOR ASPECT. SHE HAD POSTERIOR SUBLUXATION AS WELL AS ROTATIONAL DEFORMITY AND WHAT APPEARED TO BE LUCENCIES AROUND BOTH THE MEDICAL TIBIAL BASEPLATE AND THE MEDIAL CONDYLE. THERE WERE NOT ANY PARAMETERS INDICATING AN INFECTION. THERE WAS A SIGNIFICANT AMOUNT OF METALLOSIS AND BLACK SCAR SYNOVIAL TISSUE. STERILE DRESSING WAS APPLIED, THERE WERE NO COMPLICATIONS IN THE CASE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 17066863 ↗
• InjuryMay 8, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, ON (B)(6) 2009, PATIENT UNDERWENT A BILATERAL TOTAL KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH AN OPTETRAK POLYETHYLENE TIBIAL INSERT. ON (B)(6) 2021, APPROXIMATELY 12 YEARS 2 MONTHS AFTER THEIR INITIAL REPLACEMENT, THEY UNDERWENT LEFT KNEE REVISION SURGERY, WHICH INCLUDED THE REMOVAL OF THE FAILED POLYETHYLENE LINER, DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK POLYETHYLENE TIBIAL INSERT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16888868 ↗
• InjuryMar 28, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM THE LEGAL DEPARTMENT THAT ON (B)(6) 2017, A PATIENT UNDERWENT AN IRRIGATION AND DRAINAGE WITH POLYETHYLENE LINER EXCHANGE OF THE LEFT EXACTECH KNEE DEVICE SECONDARY TO ACUTE PERIPROSTHETIC JOINT INFECTION APPROXIMATELY 34 DAYS AFTER IMPLANT. A NEW EXACTECH OPTETRAK LOGIC TIBIAL INSERT WAS IMPLANTED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Implant Pain; Medical device site infection; Unspecified Infection

  MAUDE report 16626581 ↗
• InjuryOct 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL NOTIFICATION THAT A 48 YO FEMALE PATIENT, HAD AN INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2008, AND UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018, APPROXIMATELY 10 YEARS POST OP FOR REASONS UNKNOWN. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15534510 ↗
• InjuryJun 27, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY ELEVEN YEARS POST INITIAL TKA, PATIENT HAD A REVISION TO EXCHANGE FOR A NEW 12MM INSERT. DEVICE IMAGES RECEIVED CONFIRMED PROSTHESIS WEAR. RANGE OF MOTION (ROM) AND STABILITY WAS GOOD. PATIENT LAST KNOWN TO BE IN STABLE CONDITION. NO FURTHERED INFORMATION AVAILABLE. X-RAYS/PHOTOS RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 14838782 ↗
• InjuryNov 5, 2019Naturally Worn; Therapeutic or Diagnostic Output Failure; Appropriate Device Problem Term/Code Not Available

  SURGEON REVISED KNEE DUE TO POLY WEAR AND PCL FAILURE. SURGEON REMOVED ALL EXACTECH COMPONENTS, IMPLANTING A STRYKER REVISION KNEE. REP WAS NOT AT CASE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 9279393 ↗

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-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-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-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-