Optetrak 204-23-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862048325), received between Jan 5, 2022 and Oct 18, 2024 — classified as 10 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.

7 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. Aug 30, 2021Class IIOpen, 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2024Unstable; Detachment of Device or Device Component; Naturally Worn; Unstable; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 134 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, GROOVING AND DELAMINATION OF THE PATELLA RESULTING IN A GROSSLY LOOSE TIBIAL COMPONENT AS WELL AS LOOSENING OF THE FEMORAL COMPONENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Insufficient Information; Joint Laxity; Synovitis

  MAUDE report 20481690 ↗
• InjuryAug 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 72 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20002632 ↗
• InjuryJun 5, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 143 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, AND INSTABILITY. UPON REVISION OF THE EXACTECH DEVICE, PLAINTIFF'S SURGEON OBSERVED SIGNS OF PROSTHETIC LOOSENING DUE TO GROSS POLYETHYLENE WEAR AND OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19470042 ↗
• InjuryJan 5, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2009. APPROXIMATELY 9 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT 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 RIGHT KNEE FLUID WAS CLEAR. THERE WAS SIGNIFICANT SYNOVITIS DUE TO OSTEOLYSIS AND PARTICLE DISEASE. THE POLYETHYLENE WAS REMOVED. TIBIAL COMPONENT WAS LOOSE AND REMOVED. THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Fibrosis; Joint Laxity; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 18450065 ↗
• InjuryDec 29, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS 78 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED 10 YEARS POST OP. SURGEON PERFORMED A POLY EXCHANGE ¿ PATELLA LOOSE AND WORN. THE PATIENT WAS REVISED DUE TO POLY WEAR AND PATELLA LOOSENING, THE PATIENT WAS REVISED TO A 35MM PATELLA AND A SZ 3 13MM TIBIAL INSERT. FRAGMENTS OF POLYETHERLEYNE THAT WERE PRESENT IN THE KNEE JOINT WERE REMOVED. THIS TOOK ABOUT 5-15 MINUTES CAUSING NO ADVERSE EVENT AS A RESULT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING, IT WAS DISCARDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18422021 ↗
• InjuryJun 15, 2023Fracture; Fracture

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2011. THE POST OF THE TIBIAL POLY BROKE AND THE PATIENT WAS REVISED ON (B)(6) 2023. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17136603 ↗
• InjuryMay 1, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2012. THE PATIENT HAD A POLY AND PATELLA REVISION ON (B)(6) 2023 DUE TO THE COMPONENTS BEING LOOSE AND WORN. PARTS AND PIECES FELL INTO THE PATIENT WOUND SITE AND WERE REMOVED BY THE SURGEON. FRAGMENTS OF POLYETHYLENE WERE PRESENT IN THE KNEE JOINT. THERE WAS A 5-15 MINUTE SURGICAL DELAY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS A RESULT OF THE DELAY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 16843377 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 11.5 YEARS POST INITIAL LEFT SIDE TOTAL KNEE ARTHROPLASTY, THE OBESE 70 Y/O FEMALE PATIENT WAS REVISED DUE TO INFECTION. THE PATIENT HAS BILATERAL KNEE REPLACEMENTS. THE SURGEON REPLACED THE POLY AND PATELLA AS WELL AS A WASHOUT. THERE WERE FRAGMENTS OF POLYETHYLENE PRESENT IN THE KNEE JOINT. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGERY DELAY/PROLONGATION OF THE REVISION PROCEDURE. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS RECEIVED. THERE ARE NO X-RAYS AVAILABLE. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS DEVICES WERE DISCARDED BY HOSPITAL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 15902552 ↗
• InjuryJul 19, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED A (B)(6) MALE, INITIALLY IMPLANTED (B)(6) 2018 ON THE LEFT SIDE, HAD A REVISION APPROXIMATELY 3 YEARS 10 MONTHS POST INITIAL IMPLANT, TO EXCHANGE THE PATELLA AND POLY DUE TO WEAR. THE PATIENT WAS REVISED TO EXACTECH DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY AND ARE NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15053025 ↗
• InjuryJan 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY SEVEN YEARS POST TKA, PATIENT HAD A PARTIAL TIBIAL REVISION FOR AN UNKNOWN REASON. THIS IS NOT A PE LINER ISSUE DUE TO NON-CONFORMING EVOH BAGS, THERE IS NO INFORMATION RECEIVED ANY INFO OF INCIDENT AT THAT TIME, THERE IS NO COMPLAINT REGISTERED ON OUR SIDE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 13172772 ↗

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-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-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-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-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.