BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM RS AVL TIBIAL BEARING SET

    MDR report key: 7371370 · Received March 26, 2018

    Report

    Report Number
    0001825034-2018-02209
    Event Type
    Injury
    Date Received
    March 26, 2018
    Report Date
    March 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PCUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT - 9MM SHORT CPS ANCHOR PLUG, CATALOG# CP561286, LOT# 375920, 16CM RS LT SCREW EXP, CATALOG# CP114882, LOT# 367190; 47X14X70MM AVL TIBIA, CATALOG# CP114885, LOT# 367070; CPS TRANSVERSE PIN 6PK 20MM, CATALOG# 178524, LOT# 332470; 30MM 400LB SHRT CPS SPDL, CATALOG# CP114881, LOT# 366980; CUSTOM AVL TIBIAL BUSHING SET, CATALOG# CP111207, LOT# 536990; CPS NUT CO-CR-MO ALLOY, CATALOG# 178512, LOT# 964120; OSS POLY LOCK PIN, CATALOG# 150478, LOT# 695070; CUSTOM AVL LOCK RING SET OF 2, CATALOG# CP111215, LOT# 537020, CUST RS AVL YOKE SET, CATALOG# CP114884, LOT# 537030; CUST RS FEM AXLE. CATALOG# CP114886, LOT# 573110; CUST RS FEM BSHG SET, CATALOG# CP114887, LOT# 573140. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 · 1

    IT WAS REPORTED THAT PATIENT HAD AN INITIAL LEFT ARTHROPLASTY ON UNKNOWN DATE. SUBSEQUENTLY, THE SURGEON IS REQUESTING A DISTAL FEMUR EXPANDABLE IMPLANT TO TIBIA FOR A PLANNED REVISION DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212216 CUSTOM RS AVL TIBIAL BEARING SET PROTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 537050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R