BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR +3MM NECK

    MDR report key: 14112238 · Received April 14, 2022

    Report

    Report Number
    0001825034-2022-00909
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    October 9, 2019
    Report Date
    June 6, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDG
    UDI-DI
    00880304256668
    PMA / PMN Number
    K942479
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). YEAR OF BIRTH (B)(6). CONCOMITANT MEDICAL DEVICES: REF 192115 LOT 883990 BIMETRIC STEM; REF 010000665 LOT 3886967 G7 ACETABULAR CUP; REF 010000850 LOT 6207265 G7 ACETABULAR LINER. FOREIGN: COUNTRY: (B)(6). 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: 0001825034 - 2022 - 00910.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, D4, G3, H2, H3, H4, H6 H6:COMPONENT CODE: MECHANICAL (G04) - HEAD REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: DISLOCATION AND SUBLUXATION WITH A CLOSED REDUCTION. ADDITIONAL DISLOCATIONS OCCURRED PROMPTING A REVISION, THE CUP AND LINER WERE EXCHANGED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY ONE AND A HALF YEARS POST IMPLANTATION DUE TO DISLOCATIONS. THE LINER AND HEAD WERE EXCHANGED. THE STEM AND CUP REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324275 32MM MOD HEAD COCR +3MM NECK PROSTHESIS, HIP JDG ZIMMER BIOMET, INC. N/A J6083692 00880304256668

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R