BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS SHORT ANCHOR PLUG

    MDR report key: 9545317 · Received January 3, 2020

    Report

    Report Number
    0001825034-2020-00067
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    December 19, 2019
    Report Date
    March 16, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K062998
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) 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. X-RAY REVIEW INDICATES THERE IS FRACTURE OF THE PROXIMAL FEMORAL INTRAMEDULLARY STEM OF THE DISTAL FEMUR WITH VARUS ANGULATION AT THE FRACTURE SITE AND SMALL FRACTURE FRAGMENTS OF THE FEMUR ARE NOTED. BONE QUALITY APPEARS OSTEOPENIC. NOTED THAT THE LENGTH OF THE INTRAMEDULLARY PORTION OF THE IMPLANT APPEARS SHORTER THAN USUAL. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCTS: CPS XS SHT SPDL W PINS 600LBF CATALOG # 178363 LOT # 151360; 1/8 QUICK REL DRL STERILE 2PK CATALOG # 32-486265 LOT # 6107770; 1/8 QUICK REL DRL STERILE 2PK CATALOG # 32-486265 LOT # 245980; CPS NUT CO-CR-MO ALLOY CATALOG # 178512 LOT # 776380; OSS POLY TIBIAL BUSHING CATALOG # 150476 LOT # 565710; OSS REINFORCED YOKE CATALOG # 150493 LOT # 006250; OSS RS POLY FEM BUSHINGS SET/2 CATALOG # 161034 LOT # 729160; OSS RS AXLE CATALOG # 161035 LOT # 252620; CPS TRANSVERSE PIN 6PK 32MM CATALOG # 178527 LOT # 869440; OSS NON-MOD TIB PLATE SHORT 75 CATALOG # 161042 LOT # 570350; CPS/OSS 5CM TPR ADAPT W/OSS SC CATALOG # 178711 LOT # 623900; OSS RS 8.5CM SEG FMRL RIGHT CATALOG # 161123 LOT # 112800; OSS RS 7 CM MOD SEG FMRL-RT CATALOG # 161011 LOT # 508350; OSS 4CM DIAPHYSEAL SEGMENT CATALOG # 150482 LOT # 208260; OSS TIBIAL POLY BEARING 16MM CATALOG # 150412 LOT # 544420; OSS POLY LOCK PIN CATALOG # 150478 LOT # 664400. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE REQUESTED BUT NOT RETURNED BY HOSPITAL. ONCE THE INVESTIGATION  HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.  DEVICE EVALUATED BY MANUFACTURER? NOT RETURNED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ORTHOPEDIC SALVAGE PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO THE ANCHOR PLUG FRACTURING. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9614 COMPRESS SHORT ANCHOR PLUG PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 735610

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R