Optetrak 200-65-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862041135), received between Aug 30, 2022 and Apr 17, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2012. APPROXIMATELY 5 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2017. 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. SERIAL RADIOGRAPHS AND BONE SCAN DEMONSTRATE INCREASED UPTAKE IN THE DISTAL FEMUR AND TIBIA WITH WEAR OF THE POLYETHYLENE COMPONENT. SURVEILLANCE LABS WITH CBC, ESR AND CRP WERE WITHIN NORMAL LIMITS. RIGHT TKA ASEPTIC LOOSENING WITH EXTENSIVE METALLOSIS. ¿THERE WAS EXTENSIVE METALLOSIS WITHIN THE KNEE JOINT. THERE WAS NO GROSS PURULENCE..¿ THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION. REVISION RIGHT TKA. THE PATIENT WAS REVISED TO COMPETITOR'S DEVICES. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 19126467 ↗
• InjuryNov 30, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2012. APPROXIMATELY 6 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2019. 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) 2019: DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY DUE TO POLYETHYLENE WEAR "BOTH IMPLANTS CAME OUT RATHER EASILY BUT I WOULD NOT SAY THERE IS ANY GROSS ASEPTIC LOOSENING OTHER THAN THE FACT THAT THERE WAS SOME SUBSIDENCE OF THE TIBIAL COMPONENT. ALSO WAS NOTED THAT BOTH POSTERIOR ASPECTS OF THE TIBIAL POLYETHYLENE WEAR FRACTURED IN BROKEN MULTIPLE AREAS AND MULTIPLE SMALL PIECES OF POLYETHYLENE WERE FLOATING ABOUT THE KNEE. HE HAD QUITE A ROBUST AMOUNT OF SYNOVITIS THAT AGAIN I DEBRIDED AND SENT FOR EVALUATION. I ALSO NOTED A VERY LARGE AMOUNT OF POLYETHYLENE WEAR OF THE PATELLA. PATIENT WAS TAKEN THE PACU IN STABLE CONDITION."

  Patient problems: Failure of Implant; Osteolysis; Scar Tissue

  MAUDE report 18238973 ↗
• InjuryAug 30, 2022Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS PATIENT HAD AN INITIAL TKA ON (B)(6) 2010. THE PATIENT FEELS THAT HE HAS HAD COMPLICATIONS AND ISSUES RELATED TO HIS KNEE. THE PATIENT WAS REVISED IN (B)(6) 2021.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Inflammation; Insufficient Information; Joint Laxity; Joint effusion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 15319683 ↗

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-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-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-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-