BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY 28MM RLC LNR MROM SZ23

    MDR report key: 7270468 · Received February 14, 2018

    Report

    Report Number
    0001825034-2018-00934
    Event Type
    Injury
    Date Received
    February 14, 2018
    Date of Event
    June 12, 2017
    Report Date
    February 14, 2018
    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). CONCOMITANT PRODUCTS: PART 14-103652, LOT 132750- UNIV 2-HOLE SHL 52 MM LNR SZ 23, PART EP-105883, LOT 166560- EPOLY 28 MM RLC LNR MROM SZ23, PART 51-106100¸LOT 3674056- TPRLC 133 MP TYPE1 PPS SO 10.0, PART UNKNOWN, LOT UNKNOWN- UNK SCREW (20 MM), PART UNKNOWN, LOT UNKNOWN- UNK SCREW (25 MM), PART 650-1159, LOT 2015070101-DELTA CER FEM HD 28/-3 MM T1. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MFR 0001825034-2018-00933, MFR 0001825034-2018-00935. 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. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    CLINICAL STUDY (B)(6) PATIENT EXPERIENCED MODERATE PAIN AFTER ONE YEAR POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112634 EPOLY 28MM RLC LNR MROM SZ23 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 166560

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other