BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER METAGLENE

    MDR report key: 8976298 · Received September 9, 2019

    Report

    Report Number
    1818910-2019-103571
    Event Type
    Injury
    Date Received
    September 9, 2019
    Date of Event
    February 1, 2009
    Report Date
    August 20, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH:NULL. DEVICE HISTORY REVIEW:NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    ARTICLE RECEIVED ENTITLED: "ACROMIAL BASE FRACTURES AFTER REVERSE TOTAL SHOULDER ARTHROPLASTY: REPORT OF FIVE CASES", TREVOR C. WAHLQUIST, MS, ET. AL, PUBLISHED IN J SHOULDER ELBOW SURG (2011) 20, 1178-1183. AUTHORS EXAMINED THE TREATMENTS AND RESULTS OF FIVE PATIENTS WHO EXPERIENCED ACROMIAL BASE FRACTURES FOLLOWING REVERSE TOTAL SHOULDER ARTHROPLASTY. OF THE FIVE, THREE PATIENTS WERE REPORTED TO HAVE BEEN IMPLANTED WITH DEPUY REVERSE TOTAL SHOULDER ARTHROPLASTY DEVICES. THE STUDY BROKE THESE CASES DOWN INTO THE FIVE INDIVIDUAL PATIENTS. SPECIFIC PRODUCT AND LOT CODE INFORMATION WAS NOT PROVIDED FOR THE DEVICES, NOR WERE SPECIFIC DATES OF EVENTS INDICATED. THIS COMPLAINT WILL ADDRESS PATIENT 1, A (B)(6) YEAR OLD, RIGHT-HANDED WOMAN WHO UNDERWENT A DEPUY DELTA RIGHT TOTAL SHOULDER ARTHROPLASTY (RTSA) FOR TREATMENT OF A FAILED ROTATOR CUFF REPAIR 6 MONTHS PRIOR. APPROXIMATELY 10 MONTHS AFTER IMPLANTATION OF THE RTSA, PATIENT PRESENTED WITH RADIOGRAPHIC EVIDENCE OFF AN ACROMIAL BASE FRACTURE. DUE TO SIGNIFICANT ASSOCIATED PAIN AND LOSS OF FUNCTION, PATIENT WAS TREATED WITH ORIF USING COMPETITOR PLATE AND SCREW FIXATION. THERE WAS INDICATION OF MILD RADIOGRAPHIC SCAPULAR NOTCHING, WITHOUT ADDITIONAL CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769794 UNKNOWN SHOULDER METAGLENE SHOULDER METAGLENE KWS DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention