BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 LONGEVITY 10DEG LNR 32MM D

    MDR report key: 13423901 · Received February 2, 2022

    Report

    Report Number
    0001822565-2022-00276
    Event Type
    Injury
    Date Received
    February 2, 2022
    Date of Event
    January 25, 2022
    Report Date
    March 31, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    UDI-DI
    00889024518971
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000662 6911125 G7 PPS LTD ACET SHELL 50D; 11-363660 937920 36MM COCR MOD HD -6MM; UNKNOWN STEM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE LOCATION OF THE DEVICE IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPHS RECEIVED. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED A SIZE 36MM HEAD WAS USED WITH A SIZE 32MM LINER AND A G7 CUP. NO OTHER INFORMATION CAN BE OBTAINED FROM THE IMAGE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO THE MISMATCHED HEAD AND LINER COMBINATION USED. A 32MM LINER IS NOT DESIGNED TO USE A 36MM HEAD AS IT WOULD NOT SEAT IN THE LINER APPROPRIATELY AS NOTED IN THE IFU, THE INNER DIAMETER OF THE LINER MUST MATCH THE OUTER DIAMETER OF THE SELECTED FEMORAL HEAD. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN, ACETABULAR COMPONENT LOOSENING, AND SOFT TISSUE IMPINGEMENT CAUSED BY INCOMPATIBLE HEAD AND LINER COMPONENT IMPLANTATION. THE CUP. LINER AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 7 MONTHS POST IMPLANTATION DUE TO PAIN, ACETABULAR COMPONENT LOOSENING, AND SOFT TISSUE IMPINGEMENT CAUSED BY INCOMPATIBLE HEAD AND LINER COMPONENT IMPLANTATION. THE CUP. LINER AND HEAD WERE REMOVED AND REPLACED. 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
    84847 G7 LONGEVITY 10DEG LNR 32MM D PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. N/A 65038188 00889024518971

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H SEE H10 NARRATIVE