BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X30MM

    MDR report key: 10749433 · Received October 28, 2020

    Report

    Report Number
    0001825034-2020-03920
    Event Type
    Injury
    Date Received
    October 28, 2020
    Date of Event
    October 13, 2020
    Report Date
    January 29, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ADVANCED OSTEOLYSIS OF THE RIGHT HIP ARTHROPLASTY AS NOTED WITH SUSPECTED LOOSENING OF THE ACETABULAR IMPLANT. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER P0463044 ITEM NAME AVAN CMNTD SHELL SS 44MM LOT # 0000710631. ITEM NUMBER P0560044 ITEM NAME AVAN INSERT 44/22 LOT # 0000714004. ITEM NUMBER 163651 ITEM NAME 22.2MM DIA COCR MOD HD STD NK LOT # 428170. FOREIGN REPORT SOURCE: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO HOSPITAL POLICY; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 03916. 0001825034 - 2020 - 03921. 0001825034 - 2020 - 03922. 0001825034 - 2020 - 03923.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED APPROXIMATELY 8 YEARS LATER DUE TO HIP PAIN. SURGEON HAD XRAYS TAKEN AND SHOWED MOVEMENT OF THE CUP AND CAGE. SURGEON OPERATED TO REMOVE CUP AND CAGE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209838 TI LOW PROFILE SCREW 6.5X30MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 138500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R