BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFOBACIN BC R 1X40 US

    MDR report key: 18696794 · Received February 13, 2024

    Report

    Report Number
    0001825034-2024-00420
    Event Type
    Injury
    Date Received
    February 13, 2024
    Report Date
    July 22, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    K171540
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2024-00418 0001825034-2024-00419 0001825034-2024-00421. D10-MEDICAL PRODUCT SERIES A ASYMMETRIC PAT 34X8.5 ITEM# 184793 LOT# 802020 REFOBACIN BC R 1X40 US ITEM# 110034355 LOT# K0205Z49AA REFOBACIN BC R 1X40 US ITEM# 110034355 LOT# K0205Z49AA FEMUR CEMENTED PLUS RIGHT SIZE 7+ ITEM# 42504606212 LOT# 65092687 ARTICULAR SURFACE FIXED BEARING (CPS) RIGHT 16 MM HEIGHT ITEM# 42522600516 LOT# 65048304 STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +75 MM LENGTH ITEM# 42560007514 LOT# 64911556 FEMORAL DISTAL AUGMENT CEMENTED SIZE 7, 7+ 10 MM THICKNESS ITEM# 42556606210 LOT# 65042258 FEMORAL DISTAL AUGMENT CEMENTED SIZE 7, 7+ 10 MM THICKNESS ITEM# 42556606210 LOT# 65042258 TIBIA FIXED CEMENTED RIGHT SIZE D ITEM# 42542006702 LOT# 65114284 STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +75 MM LENGTH ITEM# 42560007514 LOT# 64982155 CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED UNDER THE WRONG MFR. VALENCE FRANCE HAS REPORTING RESPONSIBILITY FOR THIS BONE CEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IS EXPERIENCING SIGNIFICANT PAIN AND WAS GIVEN A GENICULAR BLOCK AND HINGED KNEE BRACE APPROXIMATELY SEVENTEEN MONTHS POST IMPLANTATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED UNDER THE WRONG MFR. VALENCE FRANCE HAS REPORTING RESPONSIBILITY FOR THIS BONE CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2306642 REFOBACIN BC R 1X40 US BONE CEMENT LOD ZIMMER BIOMET, INC. N/A K0205Z49AA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SEE H10