BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIV RNGLC SHL 52MM/L23

    MDR report key: 18897184 · Received March 13, 2024

    Report

    Report Number
    0001825034-2024-00711
    Event Type
    Injury
    Date Received
    March 13, 2024
    Date of Event
    February 19, 2024
    Report Date
    July 10, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K921301
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 103532, TI LOW PROFILE SCREW 6.5X25MM, 183090. 163653, 22.2MM DIA COCR MOD HD -3MM NK, 107230. RD115915, ARCOM RNGLOC LNR LPW 22MM, 23 245490. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2024-00710. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING OF THE CUP, THE PRODUCT WAS MANUFACTURED IN 2003 WITH ABOUT 20 YEARS OF POTENTIAL USE. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE NOT PROVIDED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. 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

    IT WAS REPORTED THE CUP WAS UNSTABLE DUE TO THE AGE OF THE IMPLANT. IMPLANT WAS TWENTY (20) YEARS OLD. SUBSEQUENTLY, THE PATIENT WAS REVISED.

    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
    1018535 UNIV RNGLC SHL 52MM/L23 PROSTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A 352570

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Hospitalization| R SEE H10 NARRATIVE