Optetrak 200-72-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10885862041227), received between Oct 14, 2019 and Jul 7, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Naturally Worn” (14 reports).

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

5 other recalls cover devices cleared under the same FDA submission (K932690); 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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YEARS AND 4 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO DISTAL FEMORAL PERIPROSTHETIC FRACTURE SECONDARY TO EXTENSIVE OSTEOLYSIS ASSOCIATED WITH PREMATURE POLYETHYLENE WEAR. THE PATIENT WAS REVISED TO COMPETITOR DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT IS DOING WELL AND IN STABLE CONDITION. NO FURTHER INFORMATION REPORTED.

  Patient problems: Bone Fracture(s); Osteolysis

  MAUDE report 22410902 ↗
• InjurySep 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 149 MONTHS AFTER A LEFT TOTAL 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 20248724 ↗
• InjurySep 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 148 MONTHS AFTER A RIGHT TOTAL 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 20247819 ↗
• InjuryJan 4, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2011. APPROXIMATELY 9 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2020. 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 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

  Patient problems: Insufficient Information

  MAUDE report 18443258 ↗
• InjuryOct 5, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2011. APPROXIMATELY 5 YEARS AND 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2017 WITH COMPETITORS PRODUCTS. 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) 2017 DIAGNOSIS: COMPLETE POLYETHYLENE FAILURE WITH METAL ON METAL ARTICULATION METALLOSIS STAINING OF THE SYNOVIUM. THEY THEN DID A SUBTOTAL SYNOVECTOMY TAKING OUT ALL TISSUE AROUND THE SYNOVIUM THAT WAS DARK AND BLACKENED AS MUCH AS WAS REASONABLE DUE TO BEING AROUND EITHER LIGAMENTOUS STRUCTURES OR NEUROVASCULAR STRUCTURES.

  Patient problems: Failure of Implant

  MAUDE report 17875425 ↗
• InjuryJun 5, 2023Unstable; Detachment of Device or Device Component; Naturally Worn; Unstable; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A FEMALE PATIENT HAD AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2012 AND THEN APPROXIMATELY 9 YEARS, 7 MONTHS LATER, ON (B)(6) 2022, THE PATIENT EXPERIENCED A REVISION SURGERY. REVISED TO COMPETITOR¿S DEVICES. REVISION OPERATIVE REPORT OF (B)(6) 2022 FOR FAILED TOTAL LEFT KNEE REPLACEMENT. INDICATIONS: RADIOGRAPHS DEMONSTRATED GROSS INSTABILITY WITH EROSION OF POSTERIOR TIBIAL TRAY. PREOPERATIVE WORK UP FOR SEPTIC VERSUS ASEPTIC LOOSENING. THE WORKUP FOR INFECTION WAS COMPLETED WITH CRP, ESR, AS WELL AS ASPIRATION FOR CELL COUNT, CULTURE, ALPHA DEFENSING; 2018 MSIS SCORE OF 1 FOR ELEVATED ESR. PROCEDURE: PRIOR TO INCISION, THE KNEE WAS FOUND TO HAVE GLOBAL LAXITY TO VARUS AND VALGUS STRESS IN FLEXION AND EXTENSION. UPON ARTHROTOMY, THERE WAS EGRESS MOTOR OIL TYPE FLUID. THERE WAS DIFFUSE METALLIC DEBRIS STAINING THE SYNOVIUM AND THE POLYETHYLENE LINER WAS ALREADY DISENGAGED FROM THE TIBIAL TRAY. THERE WAS OSTEOLYSIS ALONG POSTERIOR FEMUR, BUT IMPLANTS SEEMED GROSSLY STABLE. THE POSTERIOR RIM OF THE TIBIAL TRY WAS DEFICIENT FROM METAL-ON-METAL WEAR. A TRIAL LINER WAS UNABLE TO STAY IN PLACE, WITH FLEXION THE LINER WAS LIFTING OFF AND POP

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

  MAUDE report 17059864 ↗
• InjuryMar 22, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED BY LEGAL THAT THIS MALE PATIENT NEEDS A KNEE REVISION DUE TO THE RECALL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 16593196 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2011 AND WAS IMPLANTED WITH A OPTETRAK DEVICE. PLAINTIFF UNDERWENT A LEFT KNEE REVISION SURGERY ON (B)(6) 2018, APPROXIMATELY 7 YEARS 4 MONTHS POST INITIAL PROCEDURE AND WAS IMPLANTED WITH A DIFFERENT DEVICE. PLAINTIFF CONTINUES TO EXPERIENCE PAIN AND DISCOMFORT ON A DAILY BASIS IN BOTH OF HER KNEES WHICH LIMITS HER DAILY ACTIVITIES AND QUALITY OF LIFE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Implant Pain; Osteolysis

  MAUDE report 16378015 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL RIGHT KNEE REPLACEMENT SURGERY, ON (B)(6) 2011 AND WAS IMPLANTED WITH A OPTETRAK DEVICE. SPECIFICALLY, PLAINTIFF WAS IMPLANTED WITH A OPTETRAK POSTERIOR STABILIZED TIBIAL INSERT, ALONG WITH AN OPTETRAK STEM, OPTETRAK PATELLA, OPTETRAK SCREWS, A OPTETRAK TIBIAL TRAY, AND A OPTETRAK POSTERIOR STABILIZED FEMORAL COMPONENT. FOLLOWING THE SURGERY, PLAINTIFF BEGAN EXPERIENCING WORSENING SYMPTOMS, PAIN, INSTABILITY, EFFUSION, AND ANTALGIC GATE. PLAINTIFF UNDERWENT A RIGHT KNEE REVISION SURGERY ON (B)(6) 2018, APPROXIMATELY 7 YEARS 3 MONTHS POST INITIAL PROCEDURE AND WAS IMPLANTED WITH A DIFFERENT DEVICE. PLAINTIFF CONTINUES TO EXPERIENCE PAIN AND DISCOMFORT ON A DAILY BASIS IN BOTH OF HER KNEES WHICH LIMITS HER DAILY ACTIVITIES AND QUALITY OF LIFE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Joint effusion; Osteolysis; Pain

  MAUDE report 16375799 ↗
• InjuryFeb 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT WAS REVISED 5.5 YEARS POST INITIAL TKA, REASON FOR REVISION WAS NOT REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16303077 ↗
• InjuryOct 18, 2022Unstable; Detachment of Device or Device Component; Naturally Worn; Unstable; Detachment of Device or Device Component; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2008. THE PATIENT HAD A REVISION ON (B)(6) 2016. UPON INFORMATION AND BELIEF THE LOOSE COMPONENTS AND OSTEOLYSIS IN THE PATIENT'S LEFT KNEE WERE DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Metal Related Pathology; Osteolysis

  MAUDE report 15625017 ↗
• InjuryJul 6, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS FEMALE PATIENT HAD A REVISION ON HER RIGHT KNEE. REASON FOR THE REVISION WAS NOT REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 14933644 ↗
• InjuryMar 29, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY ELEVEN YEARS POST INITIAL TKA, THIS FEMALE PATIENT HAS A SCHEDULED REVISION TO BE DONE FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 13944690 ↗
• InjuryFeb 8, 2021Naturally Worn; Naturally Worn

  AS REPORTED, WHEN THE PATIENT WHO HAD OPTETRAK CR TOTAL KNEE ARTHROPLASTY USING CR SLOPE++ INSERT CAME TO THE OUTPATIENT CLINIC FOR REGULAR POST-OPERATIVE EXAMINATIONS, THE SURGEON OBSERVED A SUSPECTED METALOSIS DUE TO SEVERE POSTERIOR WEAR OF CR SLOPE++ TIBIAL INSERT ON THE X-RAY IMAGES. IN THE X-RAY FINDINGS, METALOSIS WAS APPARENTLY SUSPECTED BY THE TIBIAL TRAY BREAKAGE/WEAR DUE TO THE IMPINGEMENT WITH THE METALLIC FEMORAL COMPONENT THAT MIGHT BE OCCURRED AFTER THE TIBIAL INSERT WAS COMPLETELY WORN OUT. PATIENT IS SCHEDULED TO HAVE REVISION TOTAL KNEE ARTHROPLASTY. THE SURGEON DECIDED TO USE OTHER KNEE SYSTEM FOR THE REVISION SURGERY. THE DEVICES ARE STILL IMPLANTED. REVISION SURGERY IS SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 11295527 ↗
• InjuryJul 1, 2020Naturally Worn; Naturally Worn

  AS REPORTED, THERE WAS NARROWING OF THE JOINT SPACE ON THE MEDIAL SIDE ON THE RIGHT KNEE NOTED ON AN X-RAY OF A (B)(6) FEMALE PATIENT. DURING EXPOSURE THERE WAS EVIDENCE OF OSTEOLYSIS SCRATCHING OF THE FEMORAL COMPONENT COMPLETE WEAR OF THE POLY INSERT AND A WORN HOLE IN THE TIBIAL TRAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES NOT RETURNING, DISPOSED OF BY FACILITY.

  Patient problems: Failure of Implant

  MAUDE report 10219836 ↗
• InjuryOct 14, 2019Loose or Intermittent Connection; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  TIBIAL TRAY WAS LOOSE AND POLY WAS WORN. REVISED TO STEMMED TIBIAL TRAY AND CRC INSERT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THE HOSPITAL WOULD NOT ALLOW TO BE SENT OUT.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 9184422 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932690. 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-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-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-