Optetrak 208-01-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862053244), received between Sep 19, 2023 and Jan 27, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 28-DEC-2023. LEGAL CASE ¿ USA . PATIENT ID: (B)(6) LK REV 2. RELATED (B)(4) LK REV 1. IMPLANT DATE: (B)(6) 2011, DR. (B)(6), EXPLANT DATE: (B)(6) 2017, DR. (B)(6). NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. UNABLE TO LOCATE SURGEON/PATIENT/SERIAL NUMBER IN EBI. SERIAL NUMBERS PROVIDED. (B)(6), 208-25-22 - INSERT, TIBIA CONSTRAINED CONDYLAR. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K954208. CONCOMITANTS: OPTETRAK FEMORAL CONSTRAINED CONDYLAR CEMENTED (CAT. NO. UNKNOWN, SN (B)(6)). EXTENSION, FEMORAL FLUTED STEM WITH SLOT (CAT. NO. UNKNOWN, SN (B)(6)). AUGMENT, FEMORAL POSTERIOR (CAT. NO. UNKNOWN, SN (B)(6)). AUGMENT, FEMORAL DISTAL (CAT. NO. UNKNOWN, SN (B)(6)). AUGMENT, FEMORAL DISTAL (CAT. NO. UNKNOWN, SN (B)(6)). ADAPTER, FEMORAL TAPER WITH SCREW (CAT. NO. UNKNOWN, SN (B)(6)). STRYKER SIMPLEX WITH TOBRA BONE CEMENT. ORIGINAL DESCRIPTION SUMMARY: LEGAL CASE - (B)(6). PATIENT ID: (B)(6) LK REV2. REFER TO CASE- (B)(4) LK REV1. AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD THEIR FIRST LEFT KNEE REVISION SURGERY ON (B)(6) 2011. THEY SUBSEQUENTLY UNDERWE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint Laxity; Pain; Scar Tissue; Synovitis

  MAUDE report 21246512 ↗
• InjuryJan 7, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY LEGAL DOCUMENTATION, THAT APPROXIMATELY 9 YEARS AND 4 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED PROSTHESIS WEAR, INSTABILITY, FEMORAL LOOSENING, CYST(S), JOINT EFFUSION, OSTEOLYSIS, SWELLING/ EDEMA, JOINT LAXITY AND IMPLANT PAIN. REVISION OPERATIVE REPORT- THE PATIENT PRESENTED WITH A PAINFUL CONSTRAINED RIGHT KNEE REPLACEMENT. THE PATIENT WAS NOTED TO HAVE MARKED WEAR OF THE POLYETHYLENE ON X-RAY, BUT NOT GROSS EVIDENCE OF LOOSENING. HE HAD A LARGE EFFUSION AND POPLITEAL CYST THAT WAS PAINFUL. THE PATIENT HAS FAILED CONSERVATIVE MANAGEMENT INCLUDING ACTIVITY MODIFICATION AND ANTI-INFLAMMATORY MEDICATIONS. THERE WAS VERY EXTENSIVE SYNOVITIS AND A VERY THOROUGH SYNOVECTOMY OF THE JOINT WAS PERFORMED. THE POLYETHYLENE LINER WAS REMOVED. THERE WAS NOTED TO BE SEVERE WEAR OF THE LINER WITH DELAMINATION. NEXT THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AND THERE WAS A FRACTURE OF THE STEM AT THE FEMORAL COMPONENT JUNCTION. THE FEMORAL COMPONENT AND STEM WERE REMOVED. THERE WAS SIGNIFICANT FIBROUS TISSUE BENEATH IT WITH MARKED OSTEOLYSIS. THERE WAS NO EVIDENCE OF INFECTION GROSSLY ALTHOUGH MULTIPLE SPECIMENS WERE SENT TO PATHOLOGY. ATTE

  Patient problems: Cyst(s); Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Swelling/ Edema

  MAUDE report 21095535 ↗
• InjuryOct 25, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE - (B)(6). IT WAS REPORTED THAT A 65 YO PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2014, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 8 YEARS POST THE INITIAL PROCEDURE. THE PATIENT HAD BEEN SEEN BY THE SURGEON IN AN OUTPATIENT CLINIC. THE PATIENT HAD CONSTANT PAIN AND INSTABILITY THAT FAILED CONSERVATIVE TREATMENT. THE PRE-PROCEDURE DIAGNOSIS INDICATED ASEPTIC LOOSENING OF COMPONENTS, ARTHROPLASTY WEAR OF THE POLYETHYLENE LINER. THE POLYETHYLENE WAS REMOVED WITH AN OSTEOTOME WITHOUT DIFFICULTY. THE FEMORAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE AND WAS DIS-IMPACTED WITHOUT DIFFICULTY. THE TIBIAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE AND WAS DIS-IMPACTED OFF THE TIBIAL PLATEAU WITHOUT DIFFICULTY AND THERE WAS MINIMAL BONE LOSS. THE TIBIAL STEM AND BONE CEMENT WERE REMOVED. COMPETITOR¿S DEVICES WERE RE-IMPLANTED. THE PATIENT WAS TRANSFERRED TO THE POST ANESTHESIA CARE UNIT IN STABLE CONDITION WITH STABLE VITAL SIGNS HAVING TOLERATED THE PROCEDURE WELL WITHOUT APPARENT COMPLICATIONS. REVISED TO STRYKER. SERIAL #: (B)(6), CATEGORY #: 208-25-13 - CC TIBIAL INSERT SZ 5, 13MM, 510K: K954208 JWH Z-0019-2022 CONCOMITANTS: SERIAL #: (B)(6), CATEGORY #: 204-0

  Patient problems: Joint Laxity; Pain

  MAUDE report 20532451 ↗
• InjurySep 19, 2023Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2015. APPROXIMATELY 6 YEARS AND 11 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND RIGHT KNEE REVISION ON (B)(6) 2022. 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 MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF (B)(6). PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Bone Fracture(s); Insufficient Information; Osteolysis; Pain

  MAUDE report 17772195 ↗

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-