BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL®, ALPHA INSERT, HOODED, HH/32

    MDR report key: 15930130 · Received December 7, 2022

    Report

    Report Number
    0009613350-2022-00625
    Event Type
    Injury
    Date Received
    December 7, 2022
    Date of Event
    November 8, 2022
    Report Date
    February 1, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    UDI-DI
    00889024413610
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ALLOFIT® ALLOCLASSIC®, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 50/HH, ITEM#: 4244, LOT#: 2487376; FEMORAL HEAD +7X32MM DIA NS, ITEM#: 00-8018-032-14, LOT#: 61401646; TM PRIM FEM ST 11 MM EXOFF, ITEM#: 00-7864-011-20, LOT#: 61347683. REPORT SOURCE: FOREIGN: AUSTRALIA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2022-00626. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED: PRODUCT EVALUATION COULD NOT BE PERFORMED. REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. DEVICES USED FOR TREATMENT. NO MEDICAL RECORDS WERE PROVIDED. AN X-RAY WAS PROVIDED BUT WAS UNDATED. WITH THE AVAILABLE INFORMATION, 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 PATIENT UNDERWENT HIP REVISION SURGERY DUE TO OSTEOLYSIS ABOUT TWELVE (12) YEARS AFTER INITIAL SURGERY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    1471168 DURASUL®, ALPHA INSERT, HOODED, HH/32 HIP PROSTHESIS KWA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2539085 00889024413610

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H