BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB®, SCREW, ø 5.0, 42 MM

    MDR report key: 18887750 · Received March 12, 2024

    Report

    Report Number
    0009613350-2024-00094
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    December 20, 2023
    Report Date
    April 12, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    PMA / PMN Number
    K192217
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS IT WAS CONFIRMED THAT THE REPORTED EVENT WAS UNRELATED TO THE REPORTED ZB DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10. NCB®, LOCKING CAP ITEM# 0202150300 LOT# 3034939. NCB®, LOCKING CAP ITEM# 0202150300 LOT# 3059655. NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, SHORT, 115 MM ITEM# 0202263000 LOT# 2934192. NCB®, PERIPROSTHETIC TROCHANTER PLATE, RIGHT, NARROW ITEM# 0202263201 LOT# 3028988. ARCOS 15X190MM SPL TPR DIST ITEM# 11-300915 LOT# 977420. 36MM COCR MOD HD +3MM ITEM#11-363663 LOT# 553440. UNKNOWN LINER. CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH ITEM#00223200418 LOT# UNKNOWN. 3.5 MM LOCKING SCREW 14 MM LENGTH ITEM#00236901435 LOT# UNK. 3.5 MM LOCKING SCREW 38 MM LENGTH ITEM# 00236903835 LOT# UNK. 3.5 MM LOCKING SCREW 44 MM LENGTH ITEM# 00236904435 LOT# UNK LONG OST BLADE 10MM X 5 ITEM# 47-9986-021-26 LOT# 56715038. 3.5 MM LOCKING SCREW 16 MM LENGTH ITEM# 00236901635 LOT# UNK. 3.5 MM LOCKING SCREW 22 MM LENGTH ITEM# 00236903035 LOT# UNK. NCB UNICORTICAL SCR 5.0 L=16MM ITEM# 02.03151.016 LOT# UNK. NCB UNICORTICAL SCR 5.0 L=18MM ITEM# 02.03151.018 LOT# UNK. NCB UNICORTICAL SCR 5.0 L=20MM ITEM# 02.03151.020 LOT# UNK G2. REPORT SOURCE: AUSTRALIA. 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 MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2024-00093

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS IT WAS CONFIRMED THAT THE REPORTED EVENT WAS UNRELATED TO THE REPORTED ZB DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INITIAL HIP ARTHROPLASTY WAS PERFORMED APPROXIMATELY TWO YEARS AGO. SUBSEQUENTLY THE PATIENT UNDERWENT A REVISION SURGERY AS THE AS THE CUP HAD MIGRATED MEDIALLY, THE STEM WAS LOOSE, AND THERE WAS AN UNSPECIFIED INFECTION. ATTEMPTS HAVE BEEN MADE IT AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725249 NCB®, SCREW, ø 5.0, 42 MM PROSTHESIS, HIP HRS ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10 NARRATIVE.