BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS INVERSE HUMERAL PE-INLAY 36-0

    MDR report key: 3962552 · Received July 14, 2014

    Report

    Report Number
    9613350-2014-03714
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 25, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH X-RAY PICTURES WERE RECEIVED FOR REVIEW, THE MANUFACTURER DID NOT RECEIVE THE DEVICES NOR SURGICAL REPORTS FOR REVIEW. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE REASON FOR THE REVISION WAS NOT PROVIDED, BUT ONCE MORE SUBSTANTIAL INFORMATION IS RECEIVED OR THE DEVICE IS RETURNED AND INVESTIGATED, AND UPDATED REPORT WILL BE SUBMITTED ONCE THE RESULT OF THE INVESTIGATION IS MADE AVAILABLE. ZIMMER REF NUMBER CPT(B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISASSEMBLING BETWEEN THE TRABECULAR METAL BASE PLATE AND THE GLENOSPHERE TO, AND REMOVED THE TWO SCREW SYSTEM (4.5-18 AND 4.5-30) AND BOTH WERE REPLACED WITH INVERSE/REVERSE SCREW SYSTEM 4.5-30. ALSO THE AS INVERSE/REVERSE HUMERAL PE-INLAY AND THE AS INVERSE/REVERSE HUMERAL CUP, WERE REPLACED. THIS SURGERY IS REFERENCED ON CPT(B)(4). THIS REPORT AT HAND (CPT(B)(4)) CONCERNS THE REVISION OF THE AS INVERSE/REVERSE HUMERAL PE-INLAY 36-0, PART# 0104223360 WITH LOT# 2706854, THAT WAS IMPLANTED ON (B)(6) 2014 AND NOW HAS BEEN REMOVED AND REPLACED WITH ANOTHER AS INVERSE/REVERSE HUMERAL PE-INLAY 36-0 WITH LOT #2753571. THE REASON AS TO WHY THE IN-LAY WAS REVISED WAS NOT PROVIDED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409578 AS INVERSE HUMERAL PE-INLAY 36-0 ANATOMICAL SHOULDER INVERSE/REVERSE HSD ZIMMER, INC. 2754457

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R