BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS CEMENTED IM STEM 13X150

    MDR report key: 10511907 · Received September 9, 2020

    Report

    Report Number
    0001825034-2020-03477
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    February 5, 2019
    Report Date
    January 5, 2021
    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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: UDI#: (B)(4). 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. 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 · 0

    D11- MEDICAL PRODUCT OSS 7CM SEGMENTAL FEMORAL RT, ITEM# 150354 , LOT# 171250, OSS POLY TIBIAL BUSHING, ITEM# 150476 , LOT# 678220, OSS MOD TIB BASEPLATE 79MM ITEM# 150424 , LOT# 811420, OSS CEMENTED IM STEM 13MMX90MM ITEM# 150362, LOT# 169330, BMET ARCOM AP PATELLA 34MM ITEM# 11-150822, LOT# 801050, OSS AXLE ITEM# 150480, LOT# 936720, OSS REINFORCED YOKE ITEM# 150493 , LOT# 190020, OSS POLY FEMORAL BUSHINGS, ITEM# 150477 , LOT# 166910, OSS POLY LOCK PIN ITEM# 150478, LOT# 879820, OSS 3CM ELLIP DIAPHYSEAL SEG ITEM# 150461 LOT# 627580, OSS POLY FEMORAL BUSHINGS, ITEM# 150477, LOT# 420580, REFOBACIN BONE CEMENT R 1X40G, ITEM# 3003940001, LOT# A801DJ1904.

    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 REPORT: 0001825034-2020-03476. MEDICAL PRODUCT: UNKNOWN OSS FEMORAL. (B)(6). CUSTOMER HAS NOT INDICATED WHETHER OR NOT THE PRODUCT WILL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TREATMENT FOR A PERIPROSTHETIC FRACTURE AND, SUBSEQUENTLY, PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL STEM. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970745 OSS CEMENTED IM STEM 13X150 PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 379450

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R SEE H10| SEE H10