BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TM REVERSE SHOULDER POLYETHYLENE LINER

    MDR report key: 5700883 · Received June 6, 2016

    Report

    Report Number
    0001822565-2016-01909
    Event Type
    Injury
    Date Received
    June 6, 2016
    Date of Event
    May 9, 2016
    Report Date
    May 11, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED POLY LINER CONFIRMS DAMAGES ON THE ARTICULATING SURFACE AND BACK SIDE OF THE LINER. SOME OF DAMAGE MAY HAVE BEEN FROM THE REMOVAL PROCESS AND OR CONTACT WITH THE HUMERAL STEM AFTER IT DISASSOCIATED. THE LOCKING FEATURES OF THE DEVICE ARE ALSO DAMAGED. DAMAGE IS TOO SEVERE FOR DIMENSIONAL ANALYSIS. A LIGHT WITNESS MARK IS PRESENT ON THE ANTI-ROTATIONAL CUT SLOT AND IT COULD POSSIBLY HAPPEN IF THE LINER WAS NOT SUITABLY ALIGNED WITH THE STEM. THE STEM WAS NOT RETURNED SINCE IT STILL REMAINS IMPLANTED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THESE DEVICES ARE USED FOR TREATMENT. MEDWATCH SUBMITTED BY HOSPITAL TO FDA IS AVAILABLE THAT INCLUDES SURGICAL NOTES. IT WAS NOTED FROM THE EVENT DESCRIPTION SECTION IN THE MEDWATCH THAT THE PATIENT UNDERWENT SHOULDER ARTHROPLASTY REVERSE (LEFT) IN (B)(6) 2016. NO OTHER DETAIL FROM THE PRIMARY SURGERY IS PROVIDED. X RAY NOTES FROM (B)(6) 2016 AVAILABLE IN THE MEDWATCH NOTES THAT THE X-RAYS SHOWS DISLOCATION OF LEFT SHOULDER REVERSE PROSTHESIS WITH ANTERIOR POSITION. IT IS ALSO NOTED THAT THE HUMERAL COMPONENT APPEARS TO BE ROTATED ANTERIORLY AND THE GLENOID IS WELL FIXED. ATTEMPTS WERE MADE TO REDUCE THE SHOULDER IN THE OFFICE; HOWEVER IT WAS NOT POSSIBLE. REVISION NOTES ARE ALSO PROVIDED IN THE MEDWATCH EVENT DESCRIPTION SECTION. IT IS NOTED IN THE REVISION OP NOTES THAT POLY WAS FREE FLOATING OUTSIDE OF THE PROSTHESIS AND WAS REMOVED. THE HUMERAL COMPONENT WAS TESTED AND IT WAS FELT TO BE STABLE, IN GOOD POSITION AND NO EVIDENCE OF ANTEVERSION OR RETROVERSION AS SUGGESTED ON THE X-RAYS. THE GLENOSPHERE WAS ALSO FELT TO BE STABLE. IT WAS ALSO NOTED IN THE MEDWATCH THAT THE PATIENT HAD NO INJURY, NO EPISODE AND NOT OVER WORKING SHOULDER. PRODUCT HISTORY SEARCH REVEALED NO ADDITIONAL COMPLAINTS AGAINST THE RELATED PART AND LOT COMBINATIONS. THE TM REVERSE SURGICAL TECHNIQUE (97-4309-203-00) STATES: "ALSO MAKE SURE THAT THE GUIDE PIN ON THE POLY LINER IMPACTOR IS ALIGNED INTO THE POST ON THE LATERAL SIDE OF THE STEM FACE PRIOR TO IMPACTING". A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. RECEIVED, BUT NOT YET EVALUATED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS REVISED DUE TO DISLOCATION. DURING SURGERY, THE SURGEON DISCOVERED THE POLY WAS NO LONGER ON THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355922 ZIMMER TM REVERSE SHOULDER POLYETHYLENE LINER SHOULDER PROSTHESIS HSD ZIMMER, INC. N/A 62749515

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R