BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY 36MM RLC LNR MROM SZ25

    MDR report key: 7099605 · Received December 8, 2017

    Report

    Report Number
    0001825034-2017-10800
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    September 1, 2014
    Report Date
    December 8, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK070364
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: PART# 14-103658, LOT# 892470, UNIV 2-HOLE SHL 58MM LNR SZ 25; PART# 51-106170, LOT# 2802892, TPRLC 133 MP TYPE 1 PPS SO 17.0; UNK PART, UNK LOT, UNKNOWN SCREW- HIP; PART# 650-0661, LOT# 2882224, DELTA CERAMIC FEM HD 36/0MM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED AS THERE WERE NO SIMILAR ISSUES WITH THE SAME PART AND LOT NUMBER. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    SIX MONTH & 1 YEAR POST OPERATIVE MODERATE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878564 EPOLY 36MM RLC LNR MROM SZ25 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 309550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other