BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT

    MDR report key: 6352704 · Received February 23, 2017

    Report

    Report Number
    0001825034-2017-00878
    Event Type
    Injury
    Date Received
    February 23, 2017
    Date of Event
    February 13, 2017
    Report Date
    July 28, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK921182
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT: BIOMET KNEE SYSTEM PATELLA WITH WIRE, CATALOG#: 11-150826, LOT#: NI. AGC ANATOMIC FEMORAL COMPONENT, CATALOG#: 152834, LOT#: NI. BIOMET KNEE SYSTEM PATELLA WITH WIRE, CATALOG#: 11-150828, LOT#: NI. AGC KNEE SYSTEM PS MOLDED TIBIAL COMPONENT, CATALOG#: 155380, LOT#: NI. AGC ANATOMIC FEMORAL COMPONENT, CATALOG#: 152849, LOT#: NI. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE DUE TO POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134578 ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 616550

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R