Optetrak 208-01-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862053220), received between Oct 7, 2019 and Apr 16, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K954208); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REPORT #2 OF 2 FOR THIS EVENT. IT WAS REPORTED A PATIENT UNDERWENT A LEFT TOTAL KNEE REVISION PROCEDURE APPROXIMATELY THREE (3) YEARS LATER, THE PATIENT WAS DIAGNOSED WITH ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. IT WAS REPORTED THE REASON FOR THE LOOSENING WAS UNCLEAR. AS A RESULT, A YEAR LATER, THE PATIENT UNDERWENT A SECOND (2ND) REVISION PROCEDURE. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE

  Patient problems: Aseptic loosening

  MAUDE report 24905356 ↗
• InjuryNov 13, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 14 YEARS AND 1 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, OSTEOLYSIS, SYNOVITIS, CYST(S), IMPLANT PAIN AND JOINT LAXITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Cyst(s); Implant Pain; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 20672999 ↗
• InjuryOct 24, 2024Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTS THAT ON (B)(6) 2019, THE FEMALE PATIENT UNDERWENT A SECOND REVISION OF THE RIGHT EXACTECH KNEE DEVICE SECONDARY TO POLYETHYLENE LINER WEAR, APPROXIMATELY 6 YEARS 2 MONTHS AFTER THE FIRST REVISION PROCEDURE. IT IS STATED THAT DESPITE UNDERGOING THE REVISION SURGERIES, THE PATIENT EXPERIENCES DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS QUALITY OF LIFE. 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 HAS BILATERAL KNEE REPLACEMENTS.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Joint Laxity; Metal Related Pathology; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 20528057 ↗
• InjuryOct 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE - USA - DENA MARTIN LK REV 2 (B)(4). IT WAS REPORTED FROM THE LEGAL DEPARTMENT THAT ON (B)(6) 2018, A PATIENT UNDERWENT A SECOND REVISION OF THE LEFT EXACTECH KNEE DEVICE SECONDARY TO POLYETHYLENE LINER WEAR, APPROXIMATELY 6 YEARS 4 MONTHS AFTER THE FIRST REVISION. IT IS STATED THAT DESPITE UNDERGOING THE REVISION SURGERIES, THE PATIENT EXPERIENCES DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS QUALITY OF LIFE. 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. (B)(6) 204-23-15 - PS TIBIAL INSERTS SZ 3, 15MM FDA RECALL Z-0019-2022 ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K933610 CONCOMITANTS: (B)(6) 208-01-03 - CC FEMORAL SZ 3.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Emotional Changes; Joint Laxity; Metal Related Pathology; Pain; Unspecified Infection

  MAUDE report 20417681 ↗
• InjuryOct 27, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 67 Y/O MALE PATIENT'S LEFT KNEE WAS REVISED FOR A SECOND TIME. FIRST REVISION IS CAPTURED IN (B)(4). PATIENT STARTED EXPERIENCING ASEPTIC LOOSENING OF THE FEMORAL COMPONENTS IN 2022 BUT THE CAUSE IS NOT CLEAR AND WAS FINALLY REVISED IN 2023.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18023166 ↗
• InjuryJan 29, 2022Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY FOUR YEARS POST LEFT TKA, THIS FEMALE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Osteolysis; Pain

  MAUDE report 13390045 ↗
• InjuryDec 12, 2019Fracture; Fracture

  AS REPORTED BY THE KNEE REPLACEMENT STUDY, THE PATIENT EXPERIENCED BREAKING OF THE TIBIAL IMPLANT. THE EVENT IS UNLIKELY RELATED TO THE DEVICE AND TO THE PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 9457081 ↗
• InjuryOct 7, 2019Fracture; Appropriate Device Problem Term/Code Not Available; Fracture

  REVISION SURGERY OCCURRED THE SAME DAY, AFTER IT WAS DISCOVERED THAT THE KNEE PROSTHESIS (LEFT KNEE) WAS FRACTURED, AND THAT PATIENT SUFFERED FROM FUNCTIONAL IMPOTENCE : SURGEON DECIDED TO REMOVE AND CHANGE THE PROSTHESIS FOR ANOTHER IMMEDIATELY. REVISION SURGERY CONSISTED THUS IN REPLACING THE KNEE PROSTHESIS.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 9163376 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954208. One submission often covers many models, so check the product and lot details in each record.

• 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-