BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 56 MM O.D. SHELL

    MDR report key: 13770051 · Received March 15, 2022

    Report

    Report Number
    0002648920-2022-00056
    Event Type
    Injury
    Date Received
    March 15, 2022
    Report Date
    June 13, 2022
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    UDI-DI
    00889024124769
    PMA / PMN Number
    K990135
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT SUFFERED FROM 3 (THREE) DISLOCATIONS AND WAS REVISED. SINCE THEN, THE PATIENT HAS EXPERIENCED 2 (TWO) MORE DISLOCATIONS THAT HAVE BEEN CORRECTED WITH CLOSED REDUCTIONS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE DISLOCATIONS. IT WAS IDENTIFIED THAT THE HEAD AND STEM USED ARE NOT COMPATIBLE TOGETHER, HOWEVER WITH THE INFORMATION PROVIDED IT IS UNKNOWN WHETHER THE OFF-LABEL USAGE CONTRIBUTED TO THE DISLOCATION. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). EVENT DATE: UNKNOWN DAY IN (B)(6) 2019. CONCOMITANT PRODUCTS: REF 2232-04-18 / LOT 64013541, 63674177, 63853340, 63853474, 64013651 CERCLAGE CABLES. REF 6250-65-40 LOT 63764148 BONE SCREW. REF 01.00102.614 LOT 2810929 WAGNER SL FEMORAL STEM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE REMAINS IMPLANTED; 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: 0002648920 - 2022 - 00057.

    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 THE PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY PATIENT HAD 3 DISLOCATIONS AND WAS REVISED APPROXIMATELY 10 YEARS LATER. PATIENT HAS HAD 2 DISLOCATIONS SINCE REVISION WITH CLOSED REDUCTIONS APPROXIMATELY 6 MONTHS LATER. COMPONENTS REMAIN IMPLANTED. 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
    42143 LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 56 MM O.D. SHELL PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 63357496 00889024124769

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R