BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRABECULAR METAL HUMERAL STEM

    MDR report key: 1779138 · Received July 29, 2010

    Report

    Report Number
    1822565-2010-00534
    Event Type
    Injury
    Date Received
    July 29, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    ZIMMER INC
    Product Code
    HSD
    Removal / Correction Number
    1822565-7/26/2010-006-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE NORMAL FIT OF THE IMPLANT TO THE BONE PREPARATION IS INTENDED TO PROVIDE AN INTERFERENCE FIT CONDITION TO PROVIDE MECHANICAL STABILITY IN THE ABSENCE OF BONE CEMENT. DEPENDING ON PT BONE QUALITY, AND THE AMOUNT OF BONE REMOVED, THE REMAINING BONE MAY NOT ALLOW THE IMPLANT TO SEAT WITH NORMAL IMPACT FORCES IN SOME CASES. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFO REGARDING THE CORRECTIVE ACTION TAKEN. 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 UPON IMPLANTING THE STEM, THE SURGEON NOTICED THAT THE IMPLANT WAS NOT SEATING IN THE USUAL FASHION. HE ASKED TO RE-REAM DISTALLY AND PROXIMALLY. HE THEN TRIED TO PUT THE STEM DOWN ONE MORE TIME AND ENDED UP FRACTURING THE GREATER TUBEROSITY. THE FRACTURE WAS NOT DISPLACED SO IT WAS FIXED WITH THE PLACEMENT OF 5 HEAVY #5 SUTURES. THE SURGEON THEN ELECTED TO USE A SIZE 8MM STEM BECAUSE, THE PT WAS RHEUMATOID AND HE DID NOT WANT TO FRACTURE HER DISTALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL HUMERAL STEM SHOULDER PROSTHESIS HSD ZIMMER INC NA 61392762

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other