BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRABECULAR METAL HUMERAL STEM

    MDR report key: 1895290 · Received November 2, 2010

    Report

    Report Number
    1822565-2010-01041
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    June 26, 2010
    Report Date
    June 26, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWS
    Removal / Correction Number
    1822565-07/26/2010-006-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: DURING TRABECULAR METAL HUMERAL AND TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-07/26/2010-006-R FOR ADDITIONAL INFO REGARDING THE CORRECTIVE ACTION TAKEN. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE STEM WOULD NOT ADVANCE DISTALLY AND DUE TO THE FACT THE SURGEON WANTED TO AVOID CEMENTING THE IMPLANT, HE MADE THE DECISION TO REAM UP TO AN 11 AND IMPLANTED THE SIZE 10X130 STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL HUMERAL STEM EXTREMITIES PROSTHESIS KWS ZIMMER, INC. 61118511

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention