BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL, ALPHA INSERT, NN/28

    MDR report key: 16607947 · Received March 24, 2023

    Report

    Report Number
    0009613350-2023-00121
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    February 22, 2023
    Report Date
    June 22, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    UDI-DI
    00889024431874
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED EVIDENCE OF SURFACE DAMAGE/WEAR & TEAR TO THE LINER, WITH WHAT APPEARS TO BE INDENTATIONS AND MINOR SCRATCHES. IT COULD NOT BE DETERMINED IF THIS WAS CAUSED DURING EXPLANT OR THE TIME IN VIVO (APPROXIMATELY 21 YEARS). A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. RIGHT HIP ARTHROPLASTY COMPONENTS WERE ASSESSED TO BE ANATOMICALLY ALIGNED WITH NO FRACTURE OR DISLOCATION. THERE ARE AREAS OF RADIOLUCENCY AT THE BONE-METAL INTERFACES OF BOTH IMPLANTS CONSISTENT WITH OSTEOLYSIS. THIS IS GREATEST IN GRUEN ZONE I OF THE ACETABULAR IMPLANT AND GRUEN ZONES 1 AND 7 OF THE FEMORAL IMPLANT. THERE IS NO RADIOGRAPHIC EVIDENCE OF IMPLANT LOOSENING. CORRELATION WITH PRIOR RADIOGRAPHS WOULD BE HELPFUL IN ASSESSING POSSIBLE INTERVAL CHANGES IN THESE RADIOLUCENCIES SINCE THE INITIAL IMPLANT PLACEMENT. WHILE THERE IS NO RADIOGRAPHIC EVIDENCE OF IMPLANT LOOSENING, THE DEGREE OF OSTEOLYSIS AND POSSIBLE RESULTING IMPLANT MICROMOTION WOULD SUGGEST THAT REVISION COULD BE NECESSARY. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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). ECHO B-MTRC MP RP SO 17; ITEM#192817; LOT#2005587. ALLOFT-S ALLOCLASSIC SHL 62/NN; ITEM# 00000004270; LOT#2052313. ALLOCLASSIC SL STEM 7 12/14; ITEM# 00000002847; LOT#2103346. REPORT SOURCE: AUSTRALIA. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE THE ASSOCIATED REPORTS: 0009613350-2023-00122

    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 THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN. APPROXIMATELY 21 YEARS POST-IMPLANTATION. 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
    378543 METASUL, ALPHA INSERT, NN/28 HIP PROSTHESIS KWA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2091901 00889024431874

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10 NARRATIVE.