BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 36MM +3 MAXROM LNR SZ23

    MDR report key: 13385412 · Received January 28, 2022

    Report

    Report Number
    0001825034-2022-00185
    Event Type
    Injury
    Date Received
    January 28, 2022
    Date of Event
    January 7, 2022
    Report Date
    February 3, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MAY
    UDI-DI
    00880304469099
    PMA / PMN Number
    K090103
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PATIENT IN HER 50S. CONCOMITANT PRODUCTS: 650-1057- CER BIOLOXD OPTION HD 36MM- 2964345; 650-1064- CER OPTION TYPE 1 TPR SLEVE -6- 2962119; 13-104052- M/H RADIAL SOLID/APX SHL 52MM- 604150. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, REQUESTED BUT NOT RETURNED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REQUESTED BUT NOT RETURNED BY HOSPITAL.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H2; H3; H6. . REPORTED EVENT WAS UNABLE TO BE CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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 PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO IMPLANT FRACTURE. THE LIP OF THE LINER CRACKED AND HAD TO BE REMOVED. LOCKING MECHANISM WAS DAMAGED SO ENTIRE CUP WAS 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 ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751533 E-POLY 36MM +3 MAXROM LNR SZ23 PROSTHESIS, HIP MAY ZIMMER BIOMET, INC. N/A 639280 00880304469099

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R