BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCR 6.5X30 SELF-TAP

    MDR report key: 13423195 · Received February 2, 2022

    Report

    Report Number
    0001822565-2022-00282
    Event Type
    Injury
    Date Received
    February 2, 2022
    Date of Event
    December 2, 2021
    Report Date
    March 24, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024119826
    PMA / PMN Number
    K934765
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: 00625006530- BONE SCR 6.5X30 SELF-TAP- J7021983; 010000663-G7 PPS LTD ACET SHELL 52E-6944238; 110024463- G7 DUAL MOBILITY LINER 42MM E- 186810; UNKNOWN-UNKNOWN HEAD-UNKNOWN ; UNKNOWN-UNKNOWN STEM-UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2022 - 00281. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED VIA RADIOGRAPHS REVIEWED BY A HEALTH CARE PROFESSIONAL. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD 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

    IT WAS REPORTED, AFTER AN INITIAL RIGHT HIP ARTHROPLASTY THE POST OP X-RAYS REVEALED THAT THE TRILOGY SCREWS PULLED THROUGH THE G7 CUP. NO REVISION CASE SCHEDULED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296741 BONE SCR 6.5X30 SELF-TAP PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A J7021983 00889024119826

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SEE H10 NARRATIVE.