BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN-PEG CMNTD FEM MD PMA

    MDR report key: 8892739 · Received August 14, 2019

    Report

    Report Number
    3002806535-2019-00677
    Event Type
    Injury
    Date Received
    August 14, 2019
    Date of Event
    May 23, 2016
    Report Date
    November 14, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279438242
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. 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 · 0

    IT WAS REPORTED BY THE PATIENTS LEGAL COUNSEL THAT THE PATIENT SUFFERED UNKNOWN MEDICAL CONDITION POST OXFORD PARTIAL KNEE ARTHROPLASTY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXF TWIN-PEG CMNTDFEM MD PMA, CATALOG #: 161469, LOT #: 034750; MEDICAL PRODUCT: OXF UNI TIB TRAY SZ D RM PMA, CATALOG #: 154725, LOT #: 077100; MEDICAL PRODUCT: OXF ANAT BRG RT MD SIZE 3 PMA, CATALOG #: 159575, LOT #: 380260. ASSOCIATED PRODUCTS: MEDICAL PRODUCT: 1/8 QUICK REL DRL STERILE 2PK, CATALOG #: 32-486265, LOT #: 772500; MEDICAL PRODUCT: OXF SAWBLADE STRYKER CMNTD 3PK, CATALOG #: 506298, LOT #: 962269. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00678, 3002806535-2019-00679. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENTS LEGAL COUNSEL THAT THE PATIENT SUFFERED UNKNOWN MEDICAL CONDITION POST OXFORD PARTIAL KNEE ARTHROPLASTY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686724 OXF TWIN-PEG CMNTD FEM MD PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 034750 05019279438242

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization