BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEGMENTAL ARTICULAR SURFACE

    MDR report key: 8270073 · Received January 23, 2019

    Report

    Report Number
    0001822565-2019-00305
    Event Type
    Injury
    Date Received
    January 23, 2019
    Date of Event
    January 7, 2019
    Report Date
    October 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K070978
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PER PACKAGE INSERT 87-6203-755-23 ZIMMER SEGMENTAL SYSTEM: IMPLANT FRACTURE AND HYPEREXTENSION ARE KNOWN ADVERSE EFFECTS OF THIS PROCEDURE AND SYSTEM. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY EIGHT MONTHS POST-IMPLANTATION DUE TO HYPEREXTENSION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: STEM COLLAR 35 MM O.D. FOR USE WITH 16 MM OR SMALLER DIAMETER SEGMENTAL STEMS CATALOG # 00585204035 LOT # 63909932, POLYETHYLENE INSERT SIZE B CATALOG # 00585001295 LOT # 63240985, DISTAL FEMORAL COMPONENT FOR CEMENTED USE ONLY IN THE USA SIZE B RIGHT CATALOG # 00585001202 LOT # 63680910, FLUTED STEM EXTENSION STRAIGHT PRECOAT FOR CEMENTED USE ONLY 12 MM DIAMETER 130 MM LENGTH CATALOG # 00585205012 LOT # 63900643, ALLEN PLUG HDPE/BASO4 14C/28FL CATALOG # 00801102028 LOT # 6862008. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62676 SEGMENTAL ARTICULAR SURFACE KNEE PROSTHESIS KRO ZIMMER BIOMET, INC. N/A 62168713

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R