BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER

    MDR report key: 6216027 · Received December 30, 2016

    Report

    Report Number
    0001825034-2016-05226
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    November 28, 2016
    Report Date
    May 29, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES AND X-RAYS. PER THE REVISION OPERATIVE NOTES, THE PATIENT HAD MECHANICAL FAILURE WITH SEVERE BONE LOSS. THE GLENOSPHERE AND BASEPLATE WERE LOOSE WITH A LARGE DEFECT. PER THE CT SCAN RESULTS, THERE WAS SUPERIOR DISPLACEMENT OF THE SCAPULAR COMPONENT WITH ASSOCIATED 18MM BONY FRAGMENT SUGGESTIVE OF A MODERATELY DISPLACED FRACTURE FROM THE ANTERIOR ASPECT OF THE GLENOID AND SCAPULAR SPINE. THERE APPEARS TO BE A NONDISPLACED FRACTURE THROUGH THE BASE OF THE CORACOID PROCESS AS WELL. PER THE X-RAY REVIEW, "COMPLAINT SUGGESTS LOOSENING OF ALL THE SCREWS. THIS COULD BE IDENTIFIED RADIOGRAPHICALLY AS PERIPROSTHETIC LUCENCIES SURROUNDING THE SCREWS. THE ONLY IMAGES THAT SHOW THE SCREWS ARE 1, 2, AND 5. NONE OF THESE IMAGES REVEAL THIS TO BE CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). MEDICAL PRODUCT - BIOMET COMPREHENSIVE HUMERAL TRAY WITH LOCKING RING CATALOG#: 115370 LOT #:910020, BIOMET COMPREHENSIVE MINI HUMERAL STEM CATALOG #113630 LOT#836390, BIOMET HUMERAL BEARING CATALOG # XL-115363 LOT#502530. THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03745 / 03746 / 03747, 05210, 05226).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A RIGHT SHOULDER REVISION PROCEDURE APPROXIMATELY FOUR MONTHS POST-IMPLANTATION DUE TO ALLEGED PAIN, SWELLING, LOOSE SCREWS, AND BONE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865431 COMPREHENSIVE REVERSE SHOULDER PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS NI 123990

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R