Optetrak 200-05-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862039842), received between Nov 21, 2019 and Mar 23, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (7 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 18, 2026.

Recalls naming this device

1. Apr 18, 2024Class IIOpen, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2026Naturally Worn

  REPORT #2 OF 2 FOR THIS EVENT. AS REPORTED, THIS PATIENT HAD INITIAL BILATERAL TOTAL KNEE ARTHROPLASTIES, SUBSEQUENTLY, TEN (10) YEARS, EIGHT (8) MONTHS LATER, THE PATIENT EXPERIENCED LEFT KNEE PAIN, STIFFNESS, AND SWELLING. AS A RESULT, THE PATIENT UNDERWENT A REVISION OF THE LEFT KNEE DUE TO PROSTHESIS WEAR AND OSTEOLYSIS. IT WAS NOTED THE PATELLA COMPONENT WAS WORN AND THE TIBIAL POLYETHYLENE COMPONENT SHOWED SIGNIFICANT PITTING, DELAMINATION AND DISCOLORATION THAT REQUIRED IRRIGATION OF THE KNEE JOINT. ADDITIONALLY, IT WAS NOTED THE FEMORAL AND TIBIAL COMPONENTS SHOWED TO BE WELL FIXED. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. EXPLANTS WERE RETURNED FOR EVALUATION AS WELL AS IMAGES AND RADIOGRAPHS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 24664976 ↗
• InjuryMar 2, 2026Naturally Worn; Lack of Effect

  IT WAS REPORTED A 69 YO MALE PATIENT, WHO HAD A LEFT TKA, UNDERWENT A REVISION PROCEDURE, APPROXIMATELY 16 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF STIFFNESS FROM SWELLING, PAIN, AND DISSATISFACTION WITH THEIR LEFT TOTAL KNEE. DECREASED MOTION WAS PRESENT. THE PATIENT WAS SCHEDULED FOR A REVISION OF LEFT TKA POSSIBLE POLYETHYLENE SWAP VS. FEMORAL COMPONENT REVISION. THE PATIENT HAD REVISION SURGERY AND UNDERWENT A TIBIAL POLY IMPLANT SWAP AND PATELLA IMPLANT SWAP. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY IMAGES WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE DISCARDED BY THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

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

  MAUDE report 24492072 ↗
• InjuryMar 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT, INITIAL LEFT TOTAL KNEE UNDERWENT A REVISION PROCEDURE APPROXIMATELY 10 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2024. THE PATIENT UNDERWENT A FULL KNEE REVISION TO A COMPETITOR¿S PRODUCT. THE POLY SHOWED SOME OXIDATION AND DELAMINATION. THE PATELLA WAS LOOSE AND CAME OFF THE PATELLA BONE. THE FEMORAL COMPONENT WAS LOOSE AND WAS REMOVED FROM THE BONE. THE TIBIA IMPLANT WAS REMOVED FROM THE BONE. THERE WERE NO DEVICE BREAKAGES DURING THE PROCEDURE. THERE WAS A 30-45 MINUTE SURGICAL DELAY DURING THE PROCEDURE WITH NO ADVERSE EVENTS TO THE PATIENT AS A RESULT. NO X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. THEY WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21573787 ↗
• InjuryMar 3, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 3 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT PRESENTED BACK TO SURGEON'S OFFICE WITH COMPLAINTS OF THEIR KNEE. UPON EXAMINATION, POLY WEAR AND OSTEOLYSIS WAS EVIDENT. THE PATIENT WAS SCHEDULED FOR A REVISION RIGHT TOTAL KNEE ARTHROPLASTY, POSSIBLE POLY SWAP. THE PATIENT UNDERWENT A FULL KNEE REVISION TO COMPETITOR'S PRODUCTS. THE POLY SHOWED EARLY WEAR AND THE METAL IMPLANTS WERE LOOSE ON THE BONE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE. THERE WAS A GREATER THAN 45 MINUTES SURGICAL DELAY, BUT THERE WERE NO ADVERSE EVENTS AS A RESULT.

  Patient problems: Osteolysis

  MAUDE report 21504070 ↗
• InjuryFeb 20, 2025Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD BILATERAL KNEE REPLACEMENT WITH THEIR LEFT KNEE REPLACED ON (B)(6) 2016. THE PATIENT IS SCHEDULE TO HAVE LEFT KNEE REVISION ON (B)(6) 2023. THE REASON FOR REVISION HAS NOT BEEN PROVIDED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 21421486 ↗
• InjuryFeb 11, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT RIGHT TOTAL KNEE ARTHROPLASTY AND THEN APPROXIMATELY 6 YEARS, 2 MONTHS LATER, THEY EXPERIENCED A REVISION SURGERY. PATIENT PRESENTED WITH PAIN, INSTABILITY THIS WAS WORSENING OVER TIME. CLINICAL EXAMINATION IMAGING WAS CONSISTENT WITH POSSIBLE SYMPTOMATIC POLYETHYLENE WEAR. THERE WAS NO EVIDENCE OF PURULENCE. THERE WAS A SMALL EFFUSION, THERE WAS WHITE SYNOVITIS INVOLVING THE KNEE WHICH CAN BE SEEN WITH POLY WEAR. NO LOOSENING/INSTABILITY OF THE FEMORAL OR TIBIAL COMPONENTS. THERE WAS A SMALL AMOUNT OF OSTEOLYSIS EVIDENT ALONG THE LATERAL MARGIN OF THE FEMUR. THERE WAS SIGNIFICANT WEAR INVOLVING THE ANTERIOR ASPECT OF THE PATELLA. THERE WAS ENOUGH WEAR OF THE PATELLA THAT IT COULD POTENTIALLY CAUSE SOME PARTICLE DISEASE. PATELLA COMPONENT WAS REVISED. STERILE DRESSING WAS APPLIED, AND THE PATIENT WAS TRANSFERRED TO RECOVERY INSTABLE CONDITION. PATIENT WILL FOLLOW UP WITH ORTHOPEDIC CLINIC 2 WEEKS POST OP. 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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Synovitis

  MAUDE report 21355093 ↗
• InjuryDec 5, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. THE PREVIOUS LINER WAS DISLODGED FROM THE TIBIAL COMPONENT. UPON INSPECTION THERE WAS SEVERE DELAMINATION WEAR ON THE SURFACE OF THE POLYETHYLENE. BOTH TIBIAL AND FEMORAL COMPONENTS HAD AREA OF SEVERE OSTEOLYSIS LEADING TO DEBONDING AT THE BONE CEMENT JOINT. PATELLAR COMPONENT FOUND TO BE SIGNIFICANTLY WORN. THE PATIENT TOLERATED THE PROCEDURE WELL. 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.

  Patient problems: Implant Pain; Osteolysis; Scar Tissue; Swelling/ Edema

  MAUDE report 20855837 ↗
• InjuryOct 25, 2024Naturally Worn; Naturally Worn

  LEGAL CASE-USA PATIENT ID: (B)(6). IT WAS REPORTED THAT APPROXIMATELY 136 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SCAR TISSUE AND SYNOVITIS. OP REPORT NOTED POLY HAD SEVERE WEAR PATTERN AND PULSED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. SERIAL NUMBER ITEM NUMBER AND FULL DESCRIPTION (B)(6) 200-72-09 - CR TIBIAL INSERT SZ 2, 9MM, SLOPE ++ ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K082022. CONCOMITANTS: (B)(6) 200-05-26 - INSET PATELLA 26MM (B)(6) 230-03-02 - OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 2, (B)(6) 200-04-22 - CEMENTED FINNED TIB. TRA SZ 2F/2T.

  Patient problems: Scar Tissue; Synovitis

  MAUDE report 20535445 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, AVERAGE SIZE FEMALE PATIENT WITH DOB OF (B)(6) 1948 BEING REVISED DUE TO PATELLA PAIN IN RIGHT KNEE. REMOVED THE INSET PATELLA, RECUT THE SURFACE AND PLACED A RESURFACING 3 PEG PATELLA. INSERT WAS NOT WORN BUT SURGEON CHOSE TO REPLACE IT WHILE THERE WITH A SIMILAR THICKNESS INSERT. DEVICE WILL NOT RETURN DUE TO HOSPITAL POLICY ALL AVAILABLE INFORMATION HAS BEEN RECEIVED.

  Patient problems: Pain

  MAUDE report 9353427 ↗

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-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-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-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-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.