BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL LARGE DIAMETER HD 52/R

    MDR report key: 22556332 · Received July 21, 2025

    Report

    Report Number
    0009613350-2025-00612
    Event Type
    Injury
    Date Received
    July 21, 2025
    Date of Event
    May 7, 2010
    Report Date
    December 31, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    K053536
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM # 0100214058, DUROM ACET COMP 58/52 CODE R, LOT # 2407411. ITEM # 0100185146, HEAD ADAPTER M/0 12/14-18/20, LOT # 2233541. ITEM # 290039150, CLS STEM 135DEG 15.0 12/14, LOT # 2283693. G2: REPORT SOURCE GERMANY. 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.

    Additional Manufacturer Narrative · 0

    (B)(4): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A2, B4, G3, G6, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND THE PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED, PSEUDOCAPSULE EXCISED, DEEP GRAY TISSUE ENCOUNTERED, CORRODED CONE WITH CLEAR SIGNS OF METAL ABRASION. OSTEOLYTIC AREAS NOTED IN THE PROXIMAL SHAFT, DISTAL PORTION OF THE STEM REMAINS WELL FIXED AND LEFT IN PLACE. PROXIMAL FEMORAL SHAFT FILLED WITH HOMOLOGOUS BONE SUBSTITUTE, ACETABULAR WAS REMOVED, NO BONY INTEGRATION NOTED AND FINAL REPLACEMENTS PRESS FITTED WITHOUT COMPLICATIONS. A DEFINITIVE ROOT CAUSE COULD NOT 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

    IT WAS REPORTED THAT A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED. SUBSEQUENTLY, AFTER 2 YEARS AND 2 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO ELEVATED METAL IONS AND RADIOGRAPHIC EVIDENCE OF FEMORAL OSTEOLYSIS. DURING THE REVISION, THE SURGEON IDENTIFIED A CORRODED CONE WITH CLEAR SIGNS OF METAL ABRASION RESULTING IN A PSEUDOCAPSULE AND OSTEOLYTIC CHANGES IN THE PROXIMAL FEMUR. THE DEFECTS WERE FILLED WITH HOMOLOGOUS GRAFTING, BUT THE DISTAL PORTION OF THE STEM REMAINED WELL FIXED AND WAS LEFT INTACT. UPON REMOVAL OF THE ACETABULAR SHELL, NO BONE INTEGRATION WAS NOTED AND WAS REPLACED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2726271 METASUL LARGE DIAMETER HD 52/R PROSTHESIS, HIP KWA ZIMMER GMBH 2273122

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Hospitalization| R SEE H11 NARRATIVE