BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM PRIMARY TIBIAL BEARING 10MM THICK X 79/83 MM WIDE

    MDR report key: 6372756 · Received March 2, 2017

    Report

    Report Number
    0001825034-2017-01248
    Event Type
    Injury
    Date Received
    March 2, 2017
    Date of Event
    January 31, 2017
    Report Date
    June 2, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(6). "IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLY SWAP REVISION DUE TO INSTABILITY." (B)(4). REC'D BY MFR MAY 25, 2017. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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

    MEDICAL PRODUCTS - BIOMET POR PRI TIB TRAY 83MM CATALOG# 141266  LOT# 080300 , BIOMET FINNED PRI STEM 40MM CATALOG# 141314  LOT# 209860 , BMET ARCOM AP PAT 3PST 37MM LG CATALOG# 11-150844 LOT# 360920 , MAXIM POR ANA PRI FML 75 RT CATALOG# 140054 LOT# 206310 , TI LOW PROFILE SCREW 6.5X45MM CATALOG# 103536  LOT# 180780 , TI LOW PROFILE SCREW 6.5X40MM CATALOG# 103535  LOT# 141680 , TI LOW PROFILE SCREW 6.5X30MM CATALOG# 103533 LOT# 141650 , TI LOW PROFILE SCREW 6.5X30MM CATALOG# 103533 LOT# 496840. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLY SWAP REVISION DUE TO INSTABILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLY SWAP REVISION DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157125 MAXIM PRIMARY TIBIAL BEARING 10MM THICK X 79/83 MM WIDE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 790020

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R