BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48/ 42, CODE H

    MDR report key: 17377129 · Received July 24, 2023

    Report

    Report Number
    0009613350-2023-00410
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    July 18, 2014
    Report Date
    October 11, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    UDI-DI
    00889024422940
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCT WAS RETURNED FOR VISUAL EXAMINATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THIS DEVICE IS INTENDED FOR TREATMENT. NO EVALUATION OF THE PICTURES/X-RAYS AS THE REPORTED EVENT IS ALREADY KNOWN AND ADDRESSED IN A PREVIOUS CAPA. ACCORDING TO THE RECEIVED SURGICAL REPORTS, THE REPORTED EVENT CAN BE CONFIRMED. NO FURTHER INVESTIGATION REQUIRED AS THIS ISSUE IS KNOWN AND ADDRESSED IN CAPA (ERROR PATTERN: POTENTIAL EARLY REVISION OF THE ACETABULAR COMPONENT DUE TO LOOSENING, IMPLANT MIGRATION OR UNRESOLVED PAIN, HIGHER ION RELEASE). MOST LIKELY ROOT CAUSE FOR THE REPORTED EVENT IS INAPPROPRIATE USE/IMPLANTATION OF THE PRODUCT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL DEVICES: METASUL DUROM, COMPONENT FOR FEMUR, CEMENTED, 42/H; ITEM# 01.00211.142; LOT# 2233625 G2 - FOREIGN: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00409 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY SEVEN YEARS AFTER INITIAL IMPLANTATION, THE PATIENT UNDERWENT A REVISION DUE TO IMPEDED RANGE OF MOTION AND ELEVATED METAL ION LEVELS. DURING REVISION, EXTENSIVE METALLOSIS WITH A LARGE PSEUDOTUMOR AND TISSUE DAMAGE WAS NOTED. THE BONE DEFECTS RESULTED IN A FRACTURE FRAGMENT OF THE GREATER TROCHANTER DURING ACETABULAR PREPARATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804105 METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48/ 42, CODE H PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) KWA ZIMMER SWITZERLAND MANUFACTURING GMBH 2390568 00889024422940

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H