BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM COCR MOD HD +6MM NO SKIRT

    MDR report key: 11254207 · Received January 29, 2021

    Report

    Report Number
    0001825034-2021-00272
    Event Type
    Injury
    Date Received
    January 29, 2021
    Date of Event
    April 17, 2020
    Report Date
    June 17, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K974558
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G4, G7, H1, H2, H3, H4, H6, H10. CLINICAL NOTES WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT SURGICAL INTERVENTION DUE TO HIP DISLOCATION. POST DISLOCATION REPORTS RESULT IN NO PAIN AND SATISFIED RECOVERY. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE COULD NOT BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 FURTHER REPORTED THAT THE PATIENT HAD CONSUMED ALCOHOL AND HAD A FALL WHICH LED TO THE DISLOCATION.

    Additional Manufacturer Narrative · 1

    (B)(4). SOURCE: (B)(6). CONCOMITANT MEDICAL DEVICES: CATALOG NUMBER:192116 LOT NUMBER:377710 BRAND NAME: ECHO POR FMRL LAT NC; CATALOG NUMBER:010000665 LOT NUMBER: 6156002 BRAND NAME: G7 PPS LTD ACET SHELL 56F; CATALOG NUMBER:010000733 LOT NUMBER:6197741 BRAND NAME: G7 NEUTRAL ARCOMX LNR; UNKNOWN APICAL PLUG; UNKNOWN LATERALIZED NECK ANGLE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-00291. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A CLINICAL STUDY THAT THE PATIENT WAS REVISED DUE TO DISLOCATION APPROXIMATELY 2 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148262 32MM COCR MOD HD +6MM NO SKIRT PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 238300

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R SEE H10 NARRATIVE