Optetrak 200-75-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862041326), received between Mar 3, 2023 and Nov 20, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 reports).

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

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.

• InjuryNov 20, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 10 YEARS AND 5 MONTHS POST INITIAL LEFT TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT PRESENTED WITH PAIN IN THE KNEE AND A BONE SCAN SHOWED "HEAT ON KNEE". THE PATIENT WAS SCHEDULED FOR REVISION DUE TO SUSPECTED POLY WEAR. ALL IMPLANTS WERE REMOVED DUE TO OSTEOLYSIS AND THE PATIENT WAS IMPLANTED WITH A REVISION KNEE. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 20735742 ↗
• InjurySep 26, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  LEGAL CASE ¿ USA. IT WAS REPORTED THAT APPROXIMATELY 134 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN; SYNOVITIS, OSTEOLYSIS, POLYETHYLENE WEAR OF INSERT WITH CRACKING AND DELAMINATION, FRACTURE OF FEMUR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0019-2022

  Patient problems: Bone Fracture(s); Osteolysis; Pain; Synovitis

  MAUDE report 20310546 ↗
• InjuryApr 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 9 YEARS AND 5 MONTHS AFTER INITIAL IMPLANT.

  Patient problems: Failure of Implant; Metal Related Pathology; Osteolysis

  MAUDE report 19086090 ↗
• InjuryAug 17, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2010. THE DEVICE IS NOT EXPLANTED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Emotional Changes; Insufficient Information

  MAUDE report 17563389 ↗
• InjuryMay 19, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF (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 200-75-09-INSERTO TIBIAL SLOPE++ CR 5-9 MM, SERIAL NUMBER (B)(6) ON 4/28/2014. THE INSERT WAS MANUFACTURED ON 3/23/2010 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 3/23/2010 AND WAS 4.0985626283367553 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON (B)(6) 2020, APPROXIMATELY 6.0 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16969685 ↗
• InjuryMar 3, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL NOTIFICATION, THE PATIENT UNDERWENT A RIGHT TKA ON (B)(6) 2017. IN THE ENSUING TIME, THE PATIENT BEGAN TO SUFFER FROM SYMPTOMS ASSOCIATED WITH THE DEFECTS OF THE EXACTECH KNEE SYSTEM, INCLUDING PAIN AND LACK OF MOBILITY. AS A RESULTS, THE PATIENT UNDERWENT REVISION SURGERY ON OR ABOUT (B)(6) 2021. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

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

  MAUDE report 16478539 ↗