BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD -6MM

    MDR report key: 13423902 · Received February 2, 2022

    Report

    Report Number
    0001825034-2022-00238
    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
    LPH
    UDI-DI
    00887868307935
    PMA / PMN Number
    K032396
    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 PRODUCTS: 20113204 65038188 G7 LONGEVITY 10DEG LNR 32MM D; 010000662 6911125 G7 PPS LTD ACET SHELL 50D; 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2022 - 00239.

    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 RELEVANT TO THE REPORTED EVENT 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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE LOOSE CUP. 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
    84848 36MM COCR MOD HD -6MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 937920 00887868307935

    Patients

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