BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR -3MM NECK

    MDR report key: 6731316 · Received July 21, 2017

    Report

    Report Number
    0001825034-2017-04918
    Event Type
    Injury
    Date Received
    July 21, 2017
    Report Date
    December 28, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICES: ARCOMXL 32MM +3 MROM LNR SZ 22 CAT: XL-108222 LOT: 392250, ECHO POR FMRL RED NC 11X135MM CAT: 192411 LOT: 967590, UNIV 2-HOLE SHL 48MM LNR SZ 22 CAT: 14-103648 LOT: 835910. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFO. EVENT DATE (B)(6) 2015 / EXPLANT DATE (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. EXPLANTED: (B)(6) 2015. CONCOMITANT PRODUCTS: UNKNOWN HEAD P/N UNKNOWN L/N UNKNOWN; UNKNOWN LINER P/N UNKNOWN L/N UNKNOWN ; TI LOW SCREW P/N 103532 L/N 016560; RINGLOC DRILL BIT P/N 31-323230 L/N 421050; UNIVERSAL RINGLOC 2-HOLE SHELL P/N 14-103648 L/N 835910; COLLARLESS POROUS STEM P/N 192411 L/N 967590. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04916. 0001825034-2017-04918.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INTIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CLOSED REDUCTION DUE TO DISLOCATION, SECONDARY TO MALPOSITIONING OF AN UNSPECIFIED COMPONENT. THE MALPOSITIONED COMPONENT WAS REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION PROCEDURE DUE TO DISLOCATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CLOSED REDUCTION ONE YEAR POST-IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511785 32MM MOD HEAD COCR -3MM NECK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 124190

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10