BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FM HD 28X012/14

    MDR report key: 15166820 · Received August 4, 2022

    Report

    Report Number
    0001822565-2022-02293
    Event Type
    Injury
    Date Received
    August 4, 2022
    Date of Event
    July 14, 2022
    Report Date
    November 16, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: FOREIGN: COUNTRY: AUSTRALIA. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2022 - 02294.

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: COUNTRY: AUSTRALIA. H6: COMPONENT CODE: MECHANICAL (G04) - HEAD. REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF PHOTOS. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED A CERAMIC HEAD AND LINER WITH A METAL SHELL. ALL THREE COMPONENTS HAVE BIO AND DEBRIS ON THEM. NO OBVIOUS DAMAGE COULD BE OBSERVED FROM THE IMAGE. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES: ANATOMIC ALIGNMENT OF THE RIGHT HIP ARTHROPLASTY. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-02294-2.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP ARTHROPLASTY REVISION DUE TO DISLOCATION. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212089 VERSYS FM HD 28X012/14 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 54886900

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| H CAT# 00640502804 LOT# 50236400 INSERT.| CAT#00640502804 LOT#50236400 INSERT.