BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM COMPRESS ANCHOR PLUG SET

    MDR report key: 7132996 · Received December 20, 2017

    Report

    Report Number
    0001825034-2017-11303
    Event Type
    Injury
    Date Received
    December 20, 2017
    Report Date
    March 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS NOT RETURNED TO ZIMMER BIOMET. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE CURRENTLY IMPLANTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS - 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 TIB BRNG SET CATALOG# CP114883 LOT# 537050, 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.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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
    913318 CUSTOM COMPRESS ANCHOR PLUG SET PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 375920

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R