BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW SELF-TAPPING 6.5 MM DIA. 35 MM LENGTH

    MDR report key: 14550523 · Received May 31, 2022

    Report

    Report Number
    0001822565-2022-01638
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    March 23, 2022
    Report Date
    July 12, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 30103605 ¿ G7 LINER - 65256641; 110010244 ¿ G7 SHELL ¿ 65273275; 574101050 ¿ FEMORAL STEM ¿ 3066872; 00877503602 ¿ BIOLOX CERAMIC HEAD ¿ 3090857. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2022 - 01636; 0001822565 - 2022 - 01637.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REVIEW OF ADDITIONAL INFORMATION RECEIVED FROM THE REPORTER, IT WAS DETERMINED THAT THIS DEVICE DID NOT CONTRIBUTE TO THE REPORTED EVENT, AS THE DEVICE WAS NOT EXPLANTED. THE INITIAL REPORT WAS SUBMITTED ERRONEOUSLY AND SHOULD BE CONSIDERED VOID. 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

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 15 DAYS POST IMPLANTATION DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REPORTED THAT THIS DEVICE WAS NOT REVISED AND DETERMINED NONCONTRIBUTORY TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1883228 BONE SCREW SELF-TAPPING 6.5 MM DIA. 35 MM LENGTH PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A J7149850

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention| H