BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E DM LINER 28 X 38MM

    MDR report key: 10456038 · Received August 26, 2020

    Report

    Report Number
    0001822565-2020-03056
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    July 2, 2020
    Report Date
    September 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572676
    PMA / PMN Number
    K190656
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED AS THE DEVICE HAS BEEN IDENTIFIED AS BEING THE WRONG SIZE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING DEFICIENCY. ADDITIONAL ACTION HAS BEEN INITIATED USING CORRECTIVE ACTION PROCESS. 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.

    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 DEVICES: ITEM #: UNKNOWN, UNKNOWN HEAD, LOT #: UNKNOWN; ITEM #: UNKNOWN, UNKNOWN STEM, LOT #: UNKNOWN; 110010242 G7 OSSEOTI 3 HOLE SHELL 48MM C 6781911; 110024461 G7 DUAL MOBILITY LINER 38MM C 821470; 00625006515 BONE SCR 6.5X15 SELF-TAP 64676690; 00625006540 BONE SCR 6.5X40 SELF-TAP J6704298; 00625006520 BONE SCR 6.5X20 SELF-TAP 6557304. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT WAS 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 PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND THE SURGEON INDICATED THAT IMMEDIATE POST-OP FOR THE CASE HE HAD DETECTED AN ISSUE OF POTENTIAL DISLOCATION AND THOUGHT IT WAS A SOFT TISSUE ISSUE. THEY REVISED THE PATIENT THE SAME DAY AND EXCHANGED THE BEARING. THE BEARING IMPLANTED APPEARS LARGER THAN THE INTENDED 38MM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921585 VIVACIT-E DM LINER 28 X 38MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64755636 00889024572676

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R