BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC BI-POLAR 28X42MM

    MDR report key: 17720467 · Received September 11, 2023

    Report

    Report Number
    0001825034-2023-02132
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    August 16, 2023
    Report Date
    January 5, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304009110
    PMA / PMN Number
    K051569
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED A RINGLOC BI-POLAR 28X42MM, PART # 11-165208 FROM LOT 000760, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. NO ETCHINGS ARE VISIBLE ON THE RETURNED ASSEMBLY. THE RING, LINER, AND CUP ARE ASSEMBLED UPON RECEIPT. VISUAL INSPECTION FOUND DINGS ON THE RIM OF THE LINER THAT HAVE CAUSE THE RIM TO BE DEFORMED. THE RING IS ENGAGED WITH ALL OF THE FINGERS OF THE LINER AS SEEN IN THE SMALL CUTOUTS. THE LINER ROTATES FREELY WITHIN THE CUP. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES: IMPRESSIONS: 1. DISLOCATED LEFT ACETABULAR CUP, SUPERIORLY AND LIKELY POSTERIORLY. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 00-8775-028-02; 12/14 CERAMIC FEM HEAD 0X28 LOT # 3143928. 00-7848-022-01; KINECTIV MODULAR NECK BB LOT # 65753444. G2: FOREIGN: TAIWAN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 36 DAYS POST IMPLANTATION DUE TO DISLOCATION. THE DOCTOR TRIED CLOSED REDUCTION AFTER PATIENT DISLOCATION BUT WAS UNSUCCESSFUL. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127956 RINGLOC BI-POLAR 28X42MM PROSTHETIC, HIP JDI ZIMMER BIOMET, INC. N/A 000760 00880304009110

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| R