BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC FEMORAL SZ 5

    MDR report key: 21246512 · Received January 27, 2025

    Report

    Report Number
    1038671-2025-00458
    Event Type
    Injury
    Date Received
    January 27, 2025
    Date of Event
    November 28, 2011
    Report Date
    April 16, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862053244
    PMA / PMN Number
    K954208
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    B4: CORRECTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, TIBIAL LOOSENING, AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    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 UNDERWENT A SECOND LEFT KNEE REVISION ON (B)(6) 2017, APPROXIMATELY 5 YEARS 5 MONTHS AFTER THEIR PRECEDING REVISION. THE PATIENT CLAIMS TO HAVE SUFFERED PAIN SINCE THE IMPLANTED DEVICE AND CONTINUES TO FACE 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. **10 JAN 2024, (B)(6), RN-THE PATIENT HAS FILED A COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. (B)(4), 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. EBI INITIAL SURGERY SEARCH - NO RESULTS.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD THEIR FIRST LEFT KNEE REVISION SURGERY ON (B)(6)2011. THEY SUBSEQUENTLY UNDERWENT A SECOND LEFT KNEE REVISION ON (B)(6)2017, APPROXIMATELY 5 YEARS 5 MONTHS AFTER THEIR PRECEDING REVISION. THE PATIENT CLAIMS TO HAVE SUFFERED PAIN SINCE THE IMPLANTED DEVICE AND CONTINUES TO FACE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772154 CC FEMORAL SZ 5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. CC FEMORAL SZ 5 10885862053244

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Hospitalization| R UNK.