Optetrak 208-25-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862054432), received between Dec 15, 2020 and May 9, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

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

1 other recall cover devices cleared under the same FDA submission (K954208); 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 16, 2026.

Recalls naming this device

1. Aug 30, 2021Open, 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.

• InjuryMay 9, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2018. THE PATIENT MAY REQUIRE REVISION SURGERY FOR POLYETHYLENE WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19280443 ↗
• InjuryDec 3, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL RIGHT TKA, THE 69 Y/O MALE PATIENT HAD A REVISION FOR AN UNKNOWN REASON. PATIENT'S 15MM POLY WAS REPLACED WITH AN 18MM POLY. PATIENT WAS REVISED TO A CC TIBIAL INSERT SZ 5, 18MM. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN X-RAYS OR IMAGES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18253635 ↗
• InjuryJul 11, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A 65 Y/O MALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2010. APPROXIMATELY 10 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6)2021. 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 (B)(6)2021: IT WAS NOTED THAT THE TIBIAL AND FEMORAL COMPONENTS WERE WELL FIXED BUT EASILY SEPARATED FROM THE BONE CEMENT INTERFACE. POSTOPERATIVE DIAGNOSIS STATED ASEPTIC LOOSENING WITH OSTEOLYSIS AND POLY WEAR IN THE LEFT KNEE.

  Patient problems: Osteolysis; Pain

  MAUDE report 17299947 ↗
• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT TWO REVISION SURGERIES ON HIS LEFT KNEE IN SPRING 2016 FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING. IN WINTER AND FALL 2018, PLAINTIFF UNDERWENT TWO REVISION SURGERIES ON HIS LEFT KNEE FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Implant Pain

  MAUDE report 16504067 ↗
• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, IN SPRING 2016, UNDERWENT TWO REVISION SURGERIES ON HIS LEFT KNEE FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Implant Pain

  MAUDE report 16502581 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2017, DUE TO PAIN. THE REASON FOR PAIN WAS NOT REPORTED. INITIAL SURGERY DATE WAS (B)(6) 2016. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 11009311 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954208. One submission often covers many models, so check the product and lot details in each record.

• 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-