BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 40MM +3 MAXROM LNR SZ24

    MDR report key: 9608257 · Received January 20, 2020

    Report

    Report Number
    0001825034-2020-00290
    Event Type
    Injury
    Date Received
    January 20, 2020
    Date of Event
    June 27, 2018
    Report Date
    May 5, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OIY
    UDI-DI
    00880304469075
    PMA / PMN Number
    K100048
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI #: (B)(4). DEVICE WAS NOT RETURNED. 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. X-RAY REVIEW INDICATES THERE IS HISTORY OF ANTERIOR DISLOCATION NOTED ON APRIL 22, 2018. 61 YEAR OLD MALE HAS A HISTORY OF TOTAL HIP ARTHROPLASTY. THE PATIENT HAD INITIAL DISLOCATIONS AFTER SURGERY. HE WAS TREATED WITH OPEN REDUCTION AND PLACEMENT OF A (CONSTRAINED) LINER. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT(S: 650-1064 CER OPTION TYPE 1 TPR SLEVE -6 2914167; 650-1058 CER BIOLOXD OPTION HD 40MM 2904573; PT-116056 REGEN/RNGLC+ LTD 56MM SZ 24 240160; 51-108080 TPRLC 133 MP T1 PPS SO 8X101MM 6006745. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION 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 THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND SUBSEQUENTLY WAS REVISED THREE MONTHS LATER DUE DISLOCATION. THE HEAD AND LINER COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70926 E-POLY 40MM +3 MAXROM LNR SZ24 PROSTHESIS, HIP OIY ZIMMER BIOMET, INC. N/A 538330 00880304469075

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R