BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHK 12X80 CEMENTED STEM

    MDR report key: 8494677 · Received April 9, 2019

    Report

    Report Number
    3002806535-2019-00359
    Event Type
    Injury
    Date Received
    April 9, 2019
    Date of Event
    July 9, 2018
    Report Date
    September 25, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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 · 0

    IT HAS BEEN REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT AN INITIAL KNEE REPLACEMENT SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO TIBIAL COMPONENT LOOSENING. DURING THE REVISION THE SURGEON EXPERIENCED DIFFICULTIES WITH EXTRACTION OF DISTAL TIBIAL COMPONENT AND FEMORAL COMPONENT, WHICH WERE LEFT IN SITU. THE PRODUCTS WERE REMOVED DURING FURTHER REVISION.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CONCOMITANT MEDICAL PRODUCT: OFFSET TIB TRAY 2.5MM ADAPTOR, CATALOG# 141490 ,LOT# 207560; VANGUARD (TM) SSK FEMORAL, CATALOG # 183300, LOT # 460060; AGC MODULAR POST SCREW, CATALOG # 153103, LOT # 570770; RHK CEMENTED STEM, CATALOG # 159405, LOT UNKNOWN; BIOMET OFFSET TIBIAL TRAY 67MM, CATALOG # 141482, LOT # 985260; VNGD SSKPSC TIB BRG S 16X63/67, CATALOG # 183826, LOT # 467180; SERIES A PAT STD 31 3 PEG, CATALOG # 184764, LOT 494690. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2019-01022, 0001825034-2018-05848, 0001825034-2019-01017, 3002806535-2019-00358. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT AN INITIAL KNEE REPLACEMENT SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO TIBIAL COMPONENT LOOSENING. DURING THE REVISION THE SURGEON EXPERIENCED DIFFICULTIES WITH EXTRACTION OF DISTAL TIBIAL COMPONENT AND FEMORAL COMPONENT, WHICH WERE LEFT IN SITU. THE PRODUCTS WERE REMOVED DURING FURTHER REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288966 RHK 12X80 CEMENTED STEM KNEE PROSTHESIS JWH BIOMET UK LTD. N/A 1634010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R