BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NCB PLATE

    MDR report key: 19512803 · Received June 11, 2024

    Report

    Report Number
    0009613350-2024-00228
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    May 15, 2024
    Report Date
    July 22, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H3: PRODUCT INFORMATION UNKNOWN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED DUE TO MISSING REFERENCE AND LOT NUMBERS. ACCORDING TO ADDITIONAL INFORMATION, NO ALLEGATIONS TOWARDS THE REPORTED NCB PLATE WERE MADE AND IT IS STATED THAT NO NCB WAS REVISED. IT WAS REPORTED THAT THE ONLY PRODUCT REVISED WAS A FEMORAL HEAD. WITH THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED, AND NO PROBLEM WAS FOUND FOR THE REPORTED NCB PLATE. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS IT WAS CONFIRMED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS REPORT SHOULD BE CONSIDERED VOID.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: BIOLOX DELTA CER FEM HD 28/0MM T1 ITEM # 650-1158 LOT #3168329. 72MM CUP SIZE REVISION SHELL; ITEM# 00700007270; LOT# 65550395. ARCOS 17X150MM SPL TPR DIST; ITEM# 11-300817; LOT# 66031294. ARCOS CON SZ C STD 60MM; ITEM# 11-301303; LOT# 273660. AVAN CMNTD SHELL SS 58MM; ITEM# P0463058; LOT# 0001641722. AVAN E1 INSERT 28 S 58; ITEM# P0561E58; LOT# 0001683700. BONE SCREW D6.5MM L25MM; ITEM# 6624-65-25; LOT# 65959931. BONE SCREW D6.5MM L50MM; ITEM# 6624-65-50; LOT# 63445353. BONE SCREW D6.5MM L20MM; ITEM# 6624-65-20; LOT# 66024209. BONE SCREW D6.5MM L15MM; ITEM# 6624-65-15; LOT# 65871275. BONE SCREW D6.5MM L35MM; ITEM# 6250-65-35; LOT# J7241829. BONE SCREW D6.5MM L30MM; ITEM# 6250-65-30; LOT# J7488880. G2 - FOREIGN: 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 MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY ONE-MONTH POST-IMPLANTATION, THE PATIENT UNDERWENT A REVISION DUE TO GREATER TROCHANTERIC FRACTURE. ADDITIONAL INFORMATION LATER CONFIRMED THE NCB PLATE WAS NOT REVISED, NCB IMPLANT WAS PLACED ON THE FEMUR FOR THE FRACTURED GT. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS IT WAS CONFIRMED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS REPORT SHOULD BE CONSIDERED VOID.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST-IMPLANTATION, THE PATIENT UNDERWENT A REVISION DUE TO GREATER TROCHANTERIC FRACTURE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814979 UNKNOWN NCB PLATE NCB TRAUMA PROTHESIS HRS ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE.