BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL COMPONENT STEMMED

    MDR report key: 6958650 · Received October 18, 2017

    Report

    Report Number
    0002648920-2017-00641
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    August 16, 2017
    Report Date
    March 21, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS 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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: NEXGEN LPS- FLEX FEMORAL COMPONENT CAT#: 00596801752, LOT#: 62948166 . PERSONA ALL POLY PATELLA CEMENTED CAT#: 42540000035, LOT#: 63639803. NEXGEN LPS- FLEX ARTICULAR SURFACE CAT#: 00596204210, LOT#: 62176623. PALACOS R SINGLE CAT#: 00-1112-140-01, LOT#: 84924545. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565- 2017-07014, 0002648920-2017-00642, 0001822565-2017- 07015.

    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 THE FOUR MONTHS FOLLOWING THE RIGHT KNEE ARTHROPLASTY, PATIENT IS EXPERIENCING LIMITED RANGE OF MOTION, EDEMA, AND SWELLING AND HAS BEEN TREATED WITH MANIPULATION AND A CORTISONE SHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739507 TIBIAL COMPONENT STEMMED PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 63392126

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention