BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS AXLE

    MDR report key: 6907375 · Received October 2, 2017

    Report

    Report Number
    0001825034-2017-07362
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    May 26, 2010
    Report Date
    October 18, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: OSS SEGMENTAL FEMORAL, CAT#: 150354 LOT#: 598100. OSS REINFORCED YOKE, CAT#: 150493 LOT#: 378820. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. 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: 001825034-2017-07363, 0001825034-2017-07364.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07364, 0001825034-2017-07362, 0001825034-2017-07363, 0001825034-2017-09112, 0001825034-2017-09121, 0001825034-2017-09126, 0001825034-2017-09127. CONCOMITANT MEDICAL PRODUCTS: OSS 7 CM SEGMENTAL FEMORAL RT CATALOG# 150354 LOT#598100, OSS REINFORCED YOKE CATALOG#150493 LOT# 378820, OSS POLY LOCK PIN CATALOG# 150478 LOT#445140, OSS POLY FEMORAL BUSHINGS 2 PK CATALOG# 150477 LOT#562430, OSS POLY TIBIAL BUSHING CATALOG#150476 LOT# 931350, OSS TIBIAL POLY BEARING 16 MM CATALOG# 150412 LOT# 672390, OSS-K 79 MOD POROUS TI CATALOG# CP102516 LOT# 809280, CPS ANCHOR PLUG 12 MM CATALOG# 178402 LOT#020450, CPS TRANSVERSE PIN 6 PK 32 MM CATALOG# 178527 LOT# 547720, CPS CENTERING SLEEVE 14 MM CATALOG# 178536 LOT#708980, CPS SM M-H F SPINDLE 12 MM PCHA CATALOG#178472 LOT# 433020, CPS NUT CO-CR-MO ALLOY CATALOG # 178512 LOT# 746180, CPS TAPER LOCKING CAP / OSS SC CATALOG#178710 LOT# 538280, CPS/OSS 5 CM TPR ADAPT W/OSS SC CATALOG# 178711 LOT# 632260. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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 · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED SEVEN MONTHS AFTER INITIAL KNEE PROCEDURE DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686830 OSS AXLE PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 378790

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention