BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 ACETABULAR SHELL

    MDR report key: 7758723 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-06505
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    December 28, 2016
    Report Date
    September 24, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : 010000849 - G7 NEUTRAL E1 LINER 32MM E ¿ 3334821, 51-145140 - TPRLC XR MP T1 PPS 14X113MM ¿ 3011808, 650-1056 - CER BIOLOXD OPTION HD 32MM ¿ 654120, 650-1066 - CER OPT TYPE 1 TPR SLEVE 0MM ¿ 696900. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PROVIDED OPERATIVE NOTES. OPERATIVE NOTES FROM THE ARTHROSCOPY SHOWS THAT THE PATIENT HAD TENDINOPATHY REQUIRING THE RELEASE OF THE ILIOPSOAS TENDON. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE LOCATION OF THE PRODUCT IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT PRESENTED WITH PERSISTANT PAIN APPROXIMATELY 1 YEAR POST IMPLANTATION. PATIENT UNDERWENT RIGHT HIP ARTHROSCOPY WITH ILIOPSOAS TENDON RELEASE DUE TO CHRONIC ILIOPSOAS INFLAMMATION. 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
    597949 G7 ACETABULAR SHELL PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 3434528

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R