Optetrak 200-05-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862039859), received between Feb 12, 2025 and Apr 3, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 reports).

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

6 other recalls cover devices cleared under the same FDA submission (K933610); 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. Apr 18, 2024Open, Classified

   Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

   Z-2157-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Naturally Worn; Lack of Effect

  AS REPORTED, APPROXIMATELY 6 YEARS AND 2 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF STIFFNESS FROM SWELLING, PAIN, AND DISSATISFACTION WITH THEIR TOTAL KNEE. DECREASED MOTION WAS PRESENT. THE PATIENT WAS SCHEDULED FOR A REVISION OF THEIR RIGHT TOTAL KNEE ARTHROPLASTY, WITH A POSSIBLE POLYETHYLENE SWAP. THE PATIENT WAS REVISED AND UNDERWENT A TIBIAL POLY IMPLANT SWAP AND PATELLA IMPLANT SWAP. IMAGES PROVIDED SHOW WEAR OF THE TIBIAL INSERT AND PATELLA COMPONENTS. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 24784287 ↗
• InjuryApr 17, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED A 63 YO MALE PATIENT, INITIAL RIGHT TKA IN (B)(6) 2017, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 7 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON WITH COMPLAINTS OF STIFFNESS, PAIN, AND DISSATISFACTION WITH THEIR TOTAL KNEE REPLACEMENT. THE PATIENT HAS A RECALLED POLY IMPLANT. THEY WERE SCHEDULED FOR A REVISION TKA, POSSIBLE POLY SWAP. THE PATIENT HAD REVISION SURGERY IN (B)(6) 2025 AND THE POLY IMPLANT AND PATELLA IMPLANT WERE SWAPPED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE SENT TO THE LAB AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Discomfort; Loss of Range of Motion; Pain

  MAUDE report 21856360 ↗
• InjuryFeb 12, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED 9 YEARS 3 MONTHS POST INITIAL OPERATION. THE PATIENT RETURNED TO SURGEON OFFICE WITH COMPLAINTS OF STIFFNESS, PAIN, AND DISSATISFACTION WITH THEIR TOTAL KNEE REPLACEMENT. THE PATIENT HAS A RECALLED POLYETHYLENE IMPLANT. THE PATIENT WAS SCHEDULED FOR A REVISION TKA POSSIBLE POLYETHYLENE SWAP. THE PATIENT UNDERWENT A TIBIAL POLYETHYLENE IMPLANT SWAP AND A PATELLA IMPLANT SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Pain

  MAUDE report 21364735 ↗
• InjuryFeb 12, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 63 YO MALE PATIENT, INITIAL LEFT TKA IMPLANTED IN (B)(6) 2017, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 7 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD RETURNED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF STIFFNESS, PAIN, AND DISSATISFACTION WITH THEIR TOTAL KNEE REPLACEMENT. THE PATIENT HAS A RECALLED POLYETHYLENE IMPLANT. THE PATIENT WAS SCHEDULED FOR A REVISION TKA POSSIBLE POLYETHYLENE SWAP. THE TIBIAL POLYETHYLENE IMPLANT AND A PATELLA IMPLANT WERE SWAPPED. THE POLYETHYLENE WAS BROKEN IN PIECES POSTERIORLY, THE PIECES OF THE IMPLANT AND POLYETHYLENE WERE REMOVED FROM THE WOUND SITE, AND THE KNEE JOINT WAS IRRIGATED WELL. THEY WERE REPLACED WITH A TIBIAL INSERT SZ 5, 10MM, AND A 3 PEG PATELLA CEMENTED 38 MM. THERE WERE NO SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE SENT TO THE LAB AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 21363750 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K933610. 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-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-
• Z-2070-2012 · Sep 23, 2011 · Terminated
  Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 2
• Z-0347-05 · Nov 11, 2004 · Terminated
  Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.