Optetrak 200-03-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862039668), received between Dec 6, 2024 and Mar 2, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 16, 2026.

Recalls naming this device

1. Apr 18, 2024Open, 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 ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REPORT #3 OF 3 FOR THIS EVENT. IT WAS REPORTED A PATIENT HAD BILATERAL TOTAL KNEE ARTHROPLASTIES. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND SWELLING IN THE RIGHT KNEE. AS A RESULT, TEN (10) YEARS, SIX (6) MONTHS LATER, THE PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE. A REVISION OPERATIVE REPORT WAS PROVIDED. THE PATIENT WAS DIAGNOSED RIGHT KNEE OSTEOLYSIS CONSISTENT WITH POLYMERIC WEAR AND COMPONENT LOOSENING. INTRAOPERATIVELY, SYNOVITIS WAS OBSERVED AND THE PATELLA COMPONENT TO BE SOMEWHAT MOBILE. THE PATIENT WAS AWAKENED AND TRANSFERRED TO GURNEY AND BROUGHT TO RECOVERY ROOM IN A STABLE CONDITION HAVING TOLERATED THE PROCEDURE WELL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Discomfort; Osteolysis; Pain; Synovitis

  MAUDE report 24485158 ↗
• InjuryMay 27, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 97 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FRACTURE OF THE POLY LINER AND POSTERIOR MEDIAL TIBIAL COMPONENT, METALLOSIS, INSTABILITY, LIMITED MOBILITY, SWELLING, KNEE PAIN, AND A GRINDING SENSATION. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. X-RAYS REVEALED METAL ON METAL BILATERAL ARTICULATION WITH FRACTURE POSTERIOR MEDIAL RIGHT TIBIAL COMPONENT AS WELL AS POLY AND FRACTURE LEFT POSTERIOR LATERAL TIBIAL COMPONENT AND POLY. INTRAOPERATIVE FINDINGS INDICATED SEVERE BLACK TISSUE STAINING/METALLOSIS THROUGHOUT THE KNEE AND OSTEOLYSIS OF THE FEMORAL. THE POLY LINER WAS TO HAVE SEVERE WEAR. THERE WAS MILD LOOSENING OF FEMORAL COMPONENT. THE TIBIAL COMPONENT HAD FRACTURED POSTERIOR MEDIALLY WHERE THE METAL FEMORAL COMPONENT HAD BEEN ARTICULATING WITH THE METAL POSTERIOR EDGE OF THE TIBIAL COMPONENT. MULTIPLE SMALL FRAGMENTS OF THE FRACTURED POLY WERE PRESENT AND REMOVED. THE PATELLA HAD SEVERE WEAR PRESENT. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. THE PATIENT APPEARED TO HAVE TOLERATED THE PROCEDURE WELL AND W

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Metal Related Pathology; Osteolysis; Swelling/ Edema

  MAUDE report 22091196 ↗
• InjuryFeb 13, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE APPROXIMATELY 6 YEARS, 2 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT POSTOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING OF LEFT TOTAL KNEE ARTHROPLASTY AND PROSTHETIC WEAR. THE PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. INSPECTION OF THE PROSTHETIC KNEE COMPONENTS REVEALED SIGNIFICANT POLYETHYLENE WEAR ON THE LATERAL FACET OF THE PATELLA COMPONENT. THE TIBIAL POLYETHYLENE SHOWED PRONOUNCED POLYETHYLENE WEAR IN THE LATERAL COMPARTMENT. THE PATIENT WAS AWAKENED AND BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THE DEVICES WERE NOT RETURNED, THERE ARE NO IMAGES PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Implant Pain; Osteolysis; Swelling/ Edema

  MAUDE report 21376849 ↗
• InjuryDec 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 121 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, IMPLANT PAIN, SYNOVITIS, AND FAILURE OF IMPLANT. 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: Failure of Implant; Implant Pain; Synovitis

  MAUDE report 20929334 ↗
• InjuryDec 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 2 MONTHS LATER, AFTER A TOTAL RIGHT REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, FAILURE OF IMPLANT, METAL RELATED PATHOLOGY, JOINT LAXITY, AMBULATION OR POSTURAL DIFFICULTIES, SWELLING/ EDEMA, PAIN AND OSTEOLYSIS. DIAGNOSIS: CATASTROPHIC FAILURE LEFT TOTAL KNEE WITH FRACTURE OF POLY LINER AND POSTERIOR LATERAL TIBIAL COMPONENT WITH METALLOSIS, KNEE PAIN, SEVERE OSTEOLYSIS LATERAL FEMORAL CONDYLE. FINDINGS: INTRAOP PICTURES PER PATIENT CONSENT WERE OBTAINED THAT SHOWED SEVERE BLACK TISSUE STAINING/METALLOSIS THROUGHOUT KNEE AND THIS WAS THOROUGHLY DEBRIDED. MULTIPLE SMALL FRAGMENTS OF FRACTURED POLY PRESENT AND REMOVED. THE METALLOSIS CAUSED OSTEOLYSIS FEMORAL BONE WORSE LATERAL FEMORAL CONDYLE WITH LARGE DEFECT AND FRACTURE OF RIM OF LATERAL CONDYLE WITH LCL STILL INTACT AND THIS WAS DEBRIDED AS WELL. THE TIBIAL COMPONENT HAD FRACTURED POSTERIOR LATERALLY WHERE METAL FEMORAL COMPONENT HAD BEEN ARTICULATING WITH METAL POSTERIOR EDGE OF TIBIAL COMPONENT. THERE WAS SEVERE METALLOSIS STAINING PRESENT ON TIBIAL BONE AS WELL. THE PATELLAR BUTTON HAD SEVERE WEAR PRESENT AS WELL AND

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20860874 ↗

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-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-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-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-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