BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFOBACIN BC R 1X40 US

    MDR report key: 15092480 · Received July 25, 2022

    Report

    Report Number
    3006946279-2022-00082
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    June 14, 2022
    Report Date
    August 29, 2022
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    UDI-DI
    00880304990197
    PMA / PMN Number
    K171540
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL DEVICES: VANGUARD CR POR FEM-RT 67.5; ITEM# 183050; LOT# 363630, BIOMET CC CRUCIATE TRAY 67MM; ITEM# 141232; LOT# J6521694, SERIES A PAT STD 31 3 PEG; ITEM# 184764; LOT# 102270, VNGD ANT STBLZD BRG 10X67; ITEM# 189040; LOT# 374820. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: PRODUCT WAS NOT RETURNED OR PICTURES NOT PROVIDED. DEVICE EVALUATION COULD NOT BE PERFORMED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THIS DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE REVIEWED AND DID NOT SHOWED ANYTHING WHICH COULD EXPLAIN THE IMPLANT LOOSENING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL RIGHT KNEE SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LOOSENING APPROXIMATELY 2 YEARS LATER. 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
    96884 REFOBACIN BC R 1X40 US BONE CEMENT, ANTIBIOTIC LOD BIOMET FRANCE S.A.R.L. N/A 814BAK0709 00880304990197

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Hospitalization| R SEE H10 NARRATIVE.