BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 T1 PPS HO 15X150MM

    MDR report key: 12688892 · Received October 25, 2021

    Report

    Report Number
    0001825034-2021-02934
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    August 27, 2021
    Report Date
    January 12, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWL
    UDI-DI
    00880304489776
    PMA / PMN Number
    K200196
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES: PATIENT WAS REVISED FOR ACETABULAR CUP FAILURE WITH SIGNIFICANT SCARRING NOTED; THEREFORE, THE FEMORAL COMPONENT WAS REVISED WITH NO COMPLICATIONS. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: REF 00700006220 LOT 63959491 TM SHELL; REF 00710506240 LOT 64210793 LONGEVITY LINER; REF 00625006520 LOT 63010444 SCREW; REF 00625006530 LOT J6858532 SCREW; REF 00625006540 LOT 64825901 SCREW; REF 00625006540 LOT J6710215 SCREW; REF 650-1058 LOT 3043515 BIOLOX HEAD; REF 650-1066 LOT 3050922 BIOLOX SLEEVE; REF 00710506240 LOT 64210793 LONGEVITY LINER; REF 51-104150 LOT 6948764 TAPERLOC STEM; REF 00223200418 LOT 64952399 CERCLAGE WIRE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE WAS DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 02935.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT LEFT THA DUE TO FEMORAL NECK FRACTURE. SUBSEQUENTLY, PATIENT WAS REVISED TWO DAYS LATER DUE TO AN IATROGENIC ACETABULAR FRACTURE. THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY 4 MONTHS LATER DUE TO PAIN AND INSTABILITY WITH PLACEMENT OF A CUSTOM CAGE AND CONSTRAINED LINER. DURING THE REVISION, SIGNIFICANT SCARRING WAS NOTED WHICH PROMPTED THE REMOVAL OF THE FEMORAL COMPONENT. THE ACETABULAR COMPONENT WAS FOUND WELL FIXED AND INGROWN. THE CEMENTED LINER WAS REMOVED AS WELL AS THE CUP. BACKING OUT THE SCREWS WAS NOT POSSIBLE, SO THE SURGEON CUT THEM WITH A BUR SO THAT THE CUSTOM CAGE COULD BE PLACED. DUE TO INTRAOPERATIVE COMPLICATIONS, ONLY THE CUSTOM CAGE, LINER, AND SCREWS WERE PLACED. THE WOUND WAS CLOSED WITHOUT FEMORAL COMPONENTS IN PLACE, AND THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE UNIT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591267 TPRLC 133 T1 PPS HO 15X150MM PROSTHESIS, HIP KWL ZIMMER BIOMET, INC. N/A 6948764 00880304489776

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R