BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX PS DCM TIB BRNG 10X63/67MM

    MDR report key: 6507861 · Received April 20, 2017

    Report

    Report Number
    0001825034-2017-02685
    Event Type
    Injury
    Date Received
    April 20, 2017
    Date of Event
    May 14, 2013
    Report Date
    August 3, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: MAX ILK ANA OPEN PS FMRL 65 RT CATALOG# 145152 LOT# 780850, BMET ARCOM AP PAT W/WIRE 28MM CATALOG# 11-150825 LOT# 821740, BIOMET FINNED PRI STEM 40MM CATALOG# 141314 LOT# 652620, BIOMET ILOK PRI TIB TRAY 67MM CATALOG# 141212 LOT# 223760. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS ABLE TO BE CONFIRMED FROM OPERATIVE NOTES RECEIVED. DEVICE WAS NOT RECEIVED FOR EXAMINATION. PRIMARY SURGERY OP NOTES WERE NOT PROVIDED. FROM THE REVISION SURGERY OP NOTES IT WAS NOTED THAT THERE WAS PRESENCE OF CLEAR VISCOUS EFFUSION AND SYNOVITIS PRESENT AT THE PATELLA. THE PATELLA WAS FOUND TO BE WELL FIXED AND STABLE. THERE WERE FLAKES OF POLYETHYLENE THAT APPEARED TO COMING FROM TIBIAL POLYETHYLENE. ALSO NOTED THAT THERE WAS MID FLEXION INSTABILITY AND THE POLY BEARING WAS TAKEN OUT WITHOUT ANY DIFFICULTY. THERE WAS SIGNIFICANT WEAR OF THE POLY ON THE POSTERIOR CONDYLE AND THE REMAINING INFLAMMED SYNOVIUM WAS THEN REMOVED. THE FEMORAL AND TIBIAL COMPONENTS WERE FOUND TO BE WELL FIXED. 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 TRENDS WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION DUE TO PAIN, INSTABILITY, AND POLY WEAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290281 MAX PS DCM TIB BRNG 10X63/67MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 294390

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R