BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS POROUS IM STEM 15.5 X 150

    MDR report key: 8980164 · Received September 10, 2019

    Report

    Report Number
    0001825034-2019-04030
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    August 14, 2019
    Report Date
    December 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K123501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04030 AND 0001825034-2019-04031. UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: OSS 3CM ELLIP DIAPHYSEAL SEG CATALOG#: 150461 LOT#: 559480, OSS 7CM SEGMENTAL FEMORAL RT CATALOG#: 150354 LOT#: 949080, SERIES A PAT THIN 37X8.6 3 PEG CATALOG#: 150424 LOT#: 950770, OSS POLY FEMORAL BUSHINGS 2PK CATALOG#: 150477 LOT#: 771510, OSS POLY TIBIAL BUSHING CATALOG#: 150476 LOT#: 772820, OSS POLY LOCK PIN CATALOG#: 150478 LOT#: 321490, OSS AXLE CATALOG#: 150480 LOT#: 361570, OSS REINFORCED YOKE CATALOG#: 150493 LOT#: 021760, OSS TIBIAL POLY BEARING 12MM CATALOG#: 150410 LOT#: 809110. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO THE DIAPHYSEAL SEAL DISASSOCIATING FROM THE FEMORAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774124 OSS POROUS IM STEM 15.5 X 150 PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 342520

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R