BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCR 6.5X30 SELF-TAP

    MDR report key: 8648404 · Received May 28, 2019

    Report

    Report Number
    0002648920-2019-00375
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    April 4, 2019
    Report Date
    August 26, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    MRA
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI # (B)(4). REPORTED EVENT WAS CONFIRMED WITH MEDICAL RECORDS PROVIDED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT UNDERWENT A I & D PROCEDURE DUE TO INFECTION. SUPERFICIAL EFFUSION SEPARATE FROM DEEP STRUCTURES WAS OBSERVED. THERE WAS A DEEP THIGH ABSCESS THAT WAS IN CONTACT WITH THE LEFT HIP JOINT. THE WOUND WAS IRRIGATED WITH BACTISURE. DEEP DRAIN AND WOULD VAC WERE PLACED ON THE TOP LAYER. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET G7 SHELL CAT#010000662 LOT#6395394, BIOMET STEM CAT#192808 LOT# 668350, BIOMET TAPER SLEEVE CAT#650-1064 LOT#2955104, BIOMET HEAD CAT#650-1057 LOT#2955098, BIOMET LINER CAT#010000817 LOT#6354149. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT PRIMARY LEFT THA. SUBSEQUENTLY, THE PATIENT UNDERWENT AN I&D PROCEDURE APPROXIMATELY 2 MONTHS POST IMPLANTATION DUE TO INFECTION. IT WAS NOTED THE CERAMIC HEAD, LINER, SCREW AND TAPER WERE REMOVED. 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
    441214 BONE SCR 6.5X30 SELF-TAP PROSTHESIS, HIP MRA ZIMMER MANUFACTURING B.V. N/A 64228001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R