Optetrak 200-23-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862040268), received between Sep 8, 2023 and Dec 14, 2023 — 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.

2 other recalls cover devices cleared under the same FDA submission (K932776); 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.

• InjuryDec 14, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN-PERSON SITE VISIT WITH UBARMIN 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. ON 28-NOV-2023 UPDATES TO THE EXCEL LISTING WERE PROVIDED. THIS PATIENT WAS IMPLANTED WITH A CR TIBIAL INSERT SZ 3, 13MM (CAT# 200-23-13 / SERIAL# (B)(6) ON (B)(6) 2004. PATIENT WAS REVISED ON (B)(6) 2023 APPROXIMATELY 18.50 YEARS POST IMPLANT. THERE WAS NO BONE DEFECT IN FEMUR. PATIENT HAD A AORI 2A MEDIAL PLATEAU DEFECT. PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Osteolysis

  MAUDE report 18332489 ↗
• InjuryNov 9, 2023Naturally Worn; Naturally Worn

  IT WAS REPORT THAT THIS PATIENT 'S RIGHT KNEE WAS REVISED APPROXIMATELY 7.5 YEAR POST OP. PATIENT STATED EXPERIENCING PAIN AND INFLAMMATION IN 2020. INCLUDING JOINT SPILL AND POLYETHYLENE ASYMMETRY. THERE WAS MILD IMPACT TO THE TIBIAL PLATE AT THIS TIME. REVISION OCCURRED ON (B)(6) 2021 DUE TO SYNOVITIS AND SEVERE IMPACT TO THE TIBIAL PLATEAU. PATIENT OUTCOME UNKNOWN. NO IMAGES OR X-RAYS PROVIDED.

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

  MAUDE report 18100942 ↗
• InjurySep 8, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2012. THEY SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 10 YEARS 2 MONTHS POST PRIMARY PROCEDURE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Failure of Implant; Synovitis

  MAUDE report 17714287 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932776. One submission often covers many models, so check the product and lot details in each record.

• Z-0927-06 · Dec 19, 2005 · Terminated
  Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONL
• Z-1379-05 · Jun 2, 2005 · Terminated
  The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SING