BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VANGUARD CRL TIBIAL BEARING 71/75X12

    MDR report key: 6755987 · Received July 31, 2017

    Report

    Report Number
    0001825034-2017-05382
    Event Type
    Injury
    Date Received
    July 31, 2017
    Date of Event
    June 22, 2015
    Report Date
    July 16, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION, THIS REPORT WAS DETERMINED TO NOT BE REPORTABLE AS THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: REGENEREX 3 PEG SERIES A PATELLA, ITEM NUMBER: 141357, LOT NUMBER: 739320, ITEM NAME: REGENEREX PRIMARY TIBIAL TRAY 71MM, ITEM NUMBER: 141273, LOT NUMBER: 052790, ITEM NAME: VANGUARD CR POROUS FEMORAL RT 62.5, ITEM NUMBER: 183046, LOT NUMBER: 168470, ITEM NAME: MAXIM FINNED PRIMARY STEM, ITEM NUMBER: 141314, LOT NUMBER: 539870. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05380/05381/05382/05374/05377/05375/05376/05378/05379/05373. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BI-LATERAL PATIENT WHO UNDERWENT A TOTAL KNEE ARTHROPLASTY IS EXPERIENCING PAIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO REVISION HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS ALSO EXPERIENCING POPPING, CLICKING AND LOCKING OF BOTH KNEES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534622 E1 VANGUARD CRL TIBIAL BEARING 71/75X12 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 207890

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other