BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTRAINED LINER WITH CONSTRAINING RING 36 MM

    MDR report key: 10463751 · Received August 27, 2020

    Report

    Report Number
    0002648920-2020-00388
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    August 4, 2020
    Report Date
    December 9, 2020
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KWZ
    PMA / PMN Number
    K101730
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: H2; H3; H6 NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ZIMMER BONE SCR 6.5X30 SELF-TAP CAT#00625006530 LOT#62292642. ZIMMER BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, A, 36/0, TAPER 12/14 CAT#00877503602 LOT#2909462. ZIMMER MS-30®, STEM, STANDARD, CEMENTED, 8, TAPER 12/14 CAT#300049080 LOT#2915186. ZIMMER MS-30®, DISTAL CENTRALIZER, CEMENTED, ø 8/10 CAT#0100358010 LOT#2865842. FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE BEING DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 3 YEARS LATER DUE TO A SQUEAKING HIP IMPLANT. PATIENT WAS EXPERIENCING INSTABILITY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926628 CONSTRAINED LINER WITH CONSTRAINING RING 36 MM PROSTHESIS, HIP KWZ ZIMMER MANUFACTURING B.V. N/A 63097134

    Patients

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