Optetrak 204-04-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10885862047632), received between Oct 5, 2020 and Feb 5, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (11 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, SUBSEQUENTLY, SIX (6) YEARS, SEVEN (7) MONTHS LATER, THE PATIENT EXPERIENCED INCREASING PAIN. AS A RESULT, THE PATIENT UNDERWENT A REVISION PROCEDURE. A REVISION OPERATIVE REPORT WAS PROVIDED. POST OPERATIVE DIAGNOSIS NOTED ASEPTIC (NON-INFECTED) LOOSENING OF THE TIBIAL WITH LARGE METAPHYSEAL UNCONTAINED BONY DEFECT AND POLYETHYLENE WEAR. INTRAOPERATIVELY, SYNOVITIS AND SCAR TISSUE WERE OBSERVED. THE PATIENT WAS TAKEN TO THE PACU IN STABLE CONDITION. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Pain; Scar Tissue; Synovitis

  MAUDE report 24274141 ↗
• InjuryMar 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 32 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, CYST(S), AND IMPLANT PAIN. 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.

  Patient problems: Cyst(s); Implant Pain

  MAUDE report 21687237 ↗
• InjuryJan 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA PATIENT ID: (B)(6), (B)(4). ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 14-NOV-2023, 4 JAN 2024, (B)(6), RN- IMPLANT DATE: ON (B)(6) 2010, OP REPORT ATTACHED / EXPLANT DATE: ON (B)(6) 2016: POSTOPERATIVE DIAGNOSIS: SYNOVITIS, WITH ASEPTIC LOOSENING; OPEN DEBRIDEMENT AND SYNOVECTOMY WITH REVISION OF ALL 3 COMPONENTS. REVISED TO EXACTECH DEVICES. THE PATIENT WAS AWAKENED AND TAKEN TO RECOVERY IN STABLE CONDITION. REVISION OP REPORT ATTACHED. ORIGINAL DESCRIPTION SUMMARY: AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2010. APPROXIMATELY 6 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD THE FIRST LEFT KNEE REVISION. AFTER EACH OF THE LEFT TOTAL KNEE REPLACEMENT SURGERIES, THE PATIENT BEGAN TO SUFFER FROM SYMPTOMS INCLUDING BUT NOT LIMITED SO SYNOVITIS WITH ASEPTIC LOOSENING, MECHANICAL LOOSENING, PAIN AND LACK OF MOBILITY. 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. THE DEVICE, OPTETRAK HI-FLEX TI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Discomfort/Pain; Discomfort; Pain; Synovitis

  MAUDE report 21232740 ↗
• InjuryJan 24, 2025Mechanical Problem; Unstable; Device Dislodged or Dislocated; Naturally Worn; Mechanical Problem; Unstable; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 94 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, CHRONIC LEFT KNEE PAIN AND RECENT INCREASED LEFT KNEE PAIN, METAL RELATED PATHOLOGY, OSTEOLYSIS, SYNOVITIS, IMPLANT PAIN, SCAR TISSUE, JOINT LAXITY, LOSS OF RANGE OF MOTION IMPLANT. REVISION OPERATIVE REPORTS WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED FAILED LEFT KNEE REPLACEMENT. INTRAOPERATIVELY THE SURGEON NOTED THAT UPON ENTRY OF THE JOINT, EXTENSIVE GREY/BLACK SYNOVIUM WAS OBSERVED THROUGHOUT THE JOINT CONSISTENT WITH METALLOSIS REACTION. THE SURGEON NOTED THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED AND NOT LOOSE BUT OBSERVED EVIDENCE OF SEVERAL UNDERLYING AREAS OF OSTEOLYSIS ON BOTH COMPONENTS. THE PATELLAR BUTTON WAS NOTED TO HAVE SOME DELAMINATION OF THE POLYETHYLENE BUT MOSTLY INTACT WITH ONLY SLIGHT DEFORMATION AND IT WAS ELECTED TO RETAIN IT IN PLACE. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. PATIENT WAS TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 21232508 ↗
• InjuryJan 16, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 105 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT THE PATIENT UNDERWENT A REVISION SURGERY. THE PATIENT EXPERIENCED PAIN AND NOISES. A POST OPERATIVE REPORT WAS PROVIDED. POST OPERATIVE DIAGNOSIS NOTED POLYETHYLENE FAILURE, METALLOSIS AND ASEPTIC LOOSENING. INTRAOPERATIVELY THE SURGEON OBSERVED SIGNIFICANT METALLOSIS AND NECROTIC TISSUE AND SYNOVITIS. ALTHOUGH NO SIGNS OF INFECTION. THE PATELLAR COMPONENT WAS NOTED TO BE SIGNIFICANTLY LOOSE WITH METALLOSIS AND POCKETS OF DEFECT IN THE PATELLA. THE TIBIAL TRAY COMPONENT WAS REMOVED, AND THE SURGEON OBSERVED SIGNIFICANT METALLOSIS WITH NECROTIC TISSUE POSTERIORLY, POSTERIOR MEDIAL AND LATERALLY AS WELL AS A LARGE BONY DEFECT ENCOMPASSING ALMOST THE WHOLE LATERAL FEMORAL CONDYLE. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Metal Related Pathology; Pain; Synovitis; Tissue Breakdown

  MAUDE report 21171820 ↗
• InjuryJan 2, 2025Unstable; Naturally Worn; Migration; Unstable; Naturally Worn; Migration

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 136 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS MIGRATION, PROTHESIS WEAR, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, FAILURE OF IMPLANT, OSTEOLYSIS, JOINT LAXITY, SYNOVITIS AND IMPLANT PAIN. INITIAL SURGERY AND 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.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 21055429 ↗
• InjuryApr 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A TOTAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2008 AND THEN EXPERIENCED A SURGICAL REVISION ON (B)(6) 2017. REVISION SURGERY WAS APPROXIMATELY 8 YEARS, 7 MONTHS AFTER IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2017: POSTOPERATIVE DIAGNOSIS: FAILED LEFT KNEE. PREOP INDICATION: FAILED LEFT PRIMARY KNEE, WITH GROSS LOOSENING OF THE TIBIAL COMPONENT TO PERIPROSTHETIC FRACTURE. PATIENT WAS REVISED TO COMPETITOR DEVICES. FINDINGS: NEGATIVE FOR ACUTE INFLAMMATION BUT PERIPROSTHETIC FRACTURE TO THE TIBIA WITH ANTERIOR PERFORATION AND SIGNIFICANT POSTERIOR BONE LOSS ON THE TIBIA. SIGNIFICANT POLYETHYLENE WEAR AND GROSS FAILURE OF THE TIBIAL COMPONENT WITH POSTERIOR AND VARUS CLAP WITH PERFORATION AND PERIPROSTHETIC FRACTURES THROUGH THE MEDIAL TIBIAL PLATEAU. FEMORAL COMPONENT WAS SLIGHTLY INTERNALLY ROTATED. THE PATIENT TOLERATED THE PROCEDURE WELL, THERE WERE NO IMMEDIATE COMPLICATIONS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO DEVICE RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Osteolysis; Scar Tissue

  MAUDE report 19038085 ↗
• InjuryDec 4, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2017, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2006. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946561 ↗
• InjuryDec 4, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2017, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2009. THE PATIENT HAD BILATERAL KNEE ARTHROPLASTY, THE SIDE OF REVISION SURGERY WAS NOT REPORTED, LEFT SIDE DEVICES WERE USED FOR THE PURPOSE OF THIS COMPLAINT INVESTIGATION. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946485 ↗
• InjuryDec 4, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2015, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2003. THIS PATIENT HAD BILATERAL KNEE ARTHROPLASTY, THE SIDE OF REVISION WAS NOT REPORTED; THE RIGHT KNEE DEVICE WAS USED FOR THIS INVESTIGATION. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946426 ↗
• InjuryOct 30, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2012, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2003. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10760115 ↗
• InjuryOct 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2009, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2003. THE PATIENT HAD BILATERAL KNEE ARTHROPLASTY, THE SIDE OF REVISION SURGERY IS NOT REPORTED. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10681634 ↗
• InjuryOct 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2009, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2008. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10681577 ↗
• InjuryOct 12, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2008, DUE TO INSTABILITY/TIBIAL LOOSENING . INITIAL SURGERY DATE WAS (B)(6) 2002. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10661603 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2006, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2002. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10641040 ↗
• InjuryOct 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2005, DUE TO PAIN. THE REASON FOR PAIN WAS NOT REPORTED. INITIAL SURGERY DATE WAS ON (B)(6) 2002. NO ADDITIONAL INFORMATION ABOUT THE EVENT, OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 10632435 ↗

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-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-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.