Optetrak 200-03-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862039651), received between Aug 15, 2024 and Feb 26, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (7 reports).

2 FDA recall records name this device's identifier, 2 still open.

4 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. 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-2156-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Nov 21, 2023Class IIOpen, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0582-2024 · Root cause: Packaging change control · 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.

• InjuryFeb 26, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 118 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, SWELLING, STIFFNESS, OSTEOLYSIS AROUND THE PROXIMAL TIBIA, SYNOVITIS, ABNORMAL WEAR OF THE TIBIAL INSERT ON THE MEDIAL SIDE AND OXIDATION OF THE LATERAL SIDE, AND DELAMINATION OF THE PATELLA. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 21469159 ↗
• InjuryFeb 3, 2025Material Erosion; Loosening of Implant Not Related to Bone-Ingrowth; Material Erosion; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 119 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, PATELLAR COMPONENT LOOSENING, PAIN AND SWELLING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21292988 ↗
• InjuryJan 29, 2025Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 4 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2018 DUE TO ACCELERATED AND PREVENTABLE WEAR. PATIENT EXPERIENCED PROSTHESIS WEAR, INSTABILITY, LOOSENING, FAILURE OF IMPLANT, AMBULATION OR POSTURAL DIFFICULTIES, DISCOMFORT, OSTEOLYSIS, JOINT LAXITY, SWELLING/ EDEMA AND PAIN. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21264220 ↗
• InjuryJan 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IMPLANT DATE: (B)(6) 2016. EXPLANT DATE: (B)(6) 2021. THE DEVICES WERE IMPLANTED FOR APPROXIMATELY 4 YEARS, 6 MONTHS. PATIENT EXPERIENCED PROSTHESIS WEAR, INSTABILITY, FEMORAL LOOSENING, PATELLAR LOOSENING, DISCOMFORT, SYNOVITIS, PAIN AND DISTRESS. POST OPERATIVE DIAGNOSIS: MECHANICAL LOOSENING. REVISION OF ALL COMPONENTS TO OTHER NON EXACTECH COMPONENTS. UPON OPENING THE KNEE JOINT, THE FEMORAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE AND THIS WAS EASILY EXTRACTED BY HAND. SIMILARLY, THE PATELLAR COMPONENT WAS TOTALLY LOOSE AND EASILY PRIED OFF OF THE REMAINING PATELLAR BONE STOCK. STERILE DRESSINGS WERE APPLIED AND THE PATIENT WAS EXTUBATED IN STABLE CONDITION.

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

  MAUDE report 21254250 ↗
• InjuryJan 23, 2025Naturally Worn; Naturally Worn

  LEGAL CASE - USA (MASTER CASE. (B)(4). CASE NO. (B)(4). PATIENT ID: (B)(6). IT WAS REPORTED THAT APPROXIMATELY 119 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, SEVERE PAIN, SWELLING, AND INSTABILITY, TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(6) 02-012-48-3011 LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM. SERIAL NUMBER: (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. UDI: (B)(4). 510K: K111400. CONCOMITANT PRODUCTS: (B)(6) - 02-010-03-0330 - LOGIC CR FEMORAL CEM, RIGHT, SZ 3, (B)(6) - 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T, (B)(6) - 200-03-32 - ONE PEG PATELLA 32MM, (B)(6) - 201-78-25 - SMALL HEADED SHARP PIN, 1 1/8" 4 PACK, (B)(6) - 203-96-42 - 11-4132 STRYKER SYS 6 90X13/21X1.19. ORIGINAL DESCRIPTION SUMMARY: LEGAL CASE - USA, PATIENT ID: (B)(6). THIS PATIENT IS VERIFIED FOR RIGHT KNEE ON DR. (B)(6) LIST. HE HAD RIGHT KNEE REVISION ON (B)(6) 2023 WITH DR. (B)(6). POSSIBLE MATCH FOUND ON THE KNEE LIST FOR DR. (B)(6). PATIENT ID: (B)(6), SURGERY

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

  MAUDE report 21223328 ↗
• InjuryDec 9, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 9 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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: Failure of Implant; Joint Laxity; Joint effusion; Pain; Synovitis

  MAUDE report 20879571 ↗
• InjuryDec 3, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2013. THEY UNDERWENT RIGHT KNEE REVISION SURGERY (B)(6) 2023, APPROXIMATELY 9 YEARS 8 MONTHS POST PRIMARY PROCEDURE. (B)(6) 2023, OP REPORT SURGICAL FINDINGS: SIGNIFICANT SYNOVIAL FLUID WITH HYPERTROPHIC SYNOVIAL TISSUE AND GRANULOMATOUS SYNOVIUM LARGE AMOUNT AWARE OF THE MEDIAL TIBIAL INSERT AND MILD PATELLA POLYETHYLENE WEAR. THE PATIENT HAS EXPERIENCED SWELLING/ EDEMA AND PROSTHESIS WEAR. POLYETHYLENE INSERT WAS NOTED TO HAVE SIGNIFICANT WEAR OF THE MEDIAL PLATEAU. NONE OF THE IMPLANTS SHOWED EVIDENCE OF SEVERE BONE LOSS OR LOOSENING. THE PATIENT TOLERATED THE PROCEDURE WELL WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. 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; Swelling/ Edema

  MAUDE report 20836850 ↗
• InjuryNov 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A TOTAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2011 AND THEN APPROXIMATELY 12 YEARS, 11 MONTHS LATER ON (B)(6) 2024 THE PATIENT HAD A SURGICAL REVISION. REVISION OPERATIVE REPORT (B)(6) 2024-POSTOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING OF RIGHT TOTAL KNEE. PATIENT REVISED TO COMPETITOR'S DEVICES. PATIENT WITH RADIOGRAPHIC EVIDENCE OF ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS WITH AREAS OF OSTEOLYSIS IN FEMUR AND TIBIA. NEGATIVE FOR INFECTION. THERE IS EVIDENCE OF CATASTROPHIC POLYETHYLENE WEAR WITH VISUAL DETERIORATION OF THE POLYETHYLENE WITH MULTIPLE POLYETHYLENE FRAGMENTS THROUGHOUT THE KNEE. PATELLA POLYETHYLENE COMPONENT WAS UNDERMINED WITH AREAS OF OSTEOLYSIS. THE PATIENT HAS EXPERIENCED IMPLANT PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS AWAKENED AND BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION PROVIDED.

  Patient problems: Implant Pain; Osteolysis

  MAUDE report 20791161 ↗
• InjuryAug 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2018 APPROXIMATELY 6 YEARS AND 2 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); Insufficient Information; Synovitis

  MAUDE report 19991561 ↗

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-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-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-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-0019-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-1