BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAGNER SL REVISION®, SCREW FOR TRIAL STEM, L 265

    MDR report key: 14277784 · Received May 4, 2022

    Report

    Report Number
    0009613350-2022-00267
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    March 16, 2022
    Report Date
    May 30, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    JDI
    UDI-DI
    00889024277977
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL PRODUCT: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, 40/+3.5, TAPER 12/14 CATALOG#: 00-8775-040-03 ; LOT#: 2933958. WAGNER SL REVISION STEM 19/265 CATALOG#: 01.00102.619; LOT#: 3059866. G7 LONGEVITY NEUTRAL 40MM H CATALOG#:20104008 ; LOT#: 64994663. G7 PPS LTD ACET SHELL 64H CATALOG#: 01.0000.669 ; LOT#: 6129815. BONE SCR 6.5X35 SELF-TAP CATALOG#: 00625006535; LOT#: 65120781. BONE SCR 6.5X25 SELF-TAP CATALOG#: 00625006525; LOT#: J7051450. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). IN TRANSIT TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: D4 SERIAL NUMBER UNKNOWN. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRIAL LOCKING SCREW BROKE LEAVING THE DISTAL SEGMENT OF THE STEM IN THE FEMUR. AN ETO (EXTENDED TROCHANTERIC OSTEOTOMY) HAD TO BE PERFORMED TO EXTRACT THE DISTAL SEGMENT OF THE WAGNER SL STEM. PATIENT INVOLVEMENT - MORE COMPLEX SURGERY.

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218364 WAGNER SL REVISION®, SCREW FOR TRIAL STEM, L 265 HIP INSTRUMENT JDI ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN 00889024277977

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization