BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 4 130 MM

    MDR report key: 19433524 · Received May 31, 2024

    Report

    Report Number
    0002648920-2024-00171
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    May 8, 2024
    Report Date
    September 19, 2024
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    K200823
    Removal / Correction Number
    ZFA-2024-00121
    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. MECHANICAL (G04) ¿ STEM. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED STEM COVERED IN BIO-DEBRIS. NO FURTHER EVALUATION CAN BE MADE FROM THE PICTURE PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A RADIOGRAPH WAS PROVIDED AND WAS NOT REVIEWED BY A HEALTH CARE PROFESSIONAL BECAUSE THE IMAGE HAD MARKING MAKING IT HARD TO VISUALIZE BONE; SENDING IMAGE WOULD NOT ENHANCE THE INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 00801102028, LOT# 65205176 ALLEN MEDULLARY CEMENT PLUGS 1-28 MM DIAMETER. FLANGE/14 MM DIAMETER CORE. CAT# 00801803603 LOT# 64542135 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER. CAT# 010000708 LOT# 6732828 G7 BONEMASTER LTD ACET SHL 62H. CAT# 010000860 LOT# 6324047 G7 NEUTRAL E1 LINER 36MM H. G2: FOREIGN: AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY 3 YEARS LATER DUE TO PERIPROSTHETIC FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453683 CPT FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 4 130 MM PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 62660433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11 NARRATIVE