BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY 28MM RLC LNR MROM SZ23

    MDR report key: 6691783 · Received July 6, 2017

    Report

    Report Number
    0001825034-2017-04582
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    May 21, 2017
    Report Date
    October 21, 2019
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK070364
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS WERE RECEIVED, HOWEVER, THE REPORTED EVENT IS UNABLE TO BE CONFIRMED. PATIENT HAS A HISTORY OF HEART DISEASE AND AVASCULAR NECROSIS. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(6). CONCOMITANT MEDICAL PRODUCTS: DELTA CER FEM HD 28/-3 MM T1 CATALOG#: 650-1159 LOT#: 2015070101, UNIV 2-HOLE SHL 52 MM LNR SZ 23 CATALOG#: 14-103652 LOT#: 132750, TPRLC 133 MP TYPE1 PPS SO 10.0 CATALOG#: 51-106100 LOT#: 3674056. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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

    THE COMPLAINT NUMBER CORRESPONDING TO THIS MEDWATCH IS (B)(4). IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED DISLOCATION APPROXIMATELY ONE YEAR POST IMPLANTATION. APPROXIMATELY 6 MONTHS LATER PATIENT EXPERIENCED ANOTHER DISLOCATION AND A THIRD DISLOCATION APPROXIMATELY 7 MONTHS LATER. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CLOSE REDUCTION APPROXIMATELY 1 YEAR POST PRIMARY TOTAL HIP REPLACEMENT SURGERY, DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP CLOSED REDUCTION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470978 EPOLY 28MM RLC LNR MROM SZ23 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 166560

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R