BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS HMRL TI TRAY 44MM

    MDR report key: 6497507 · Received April 17, 2017

    Report

    Report Number
    0001825034-2017-02606
    Event Type
    Injury
    Date Received
    April 17, 2017
    Date of Event
    February 24, 2017
    Report Date
    November 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    Z-1103-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: ARCOM XL 44-36 STANDARD HUMERAL BEARING, CAT#: XL-115363, LOT#: 429960; VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER, CAT#: 118001, LOT#: 456360; COMPREHENSIVE PRIMARY STEM 17 MM STANDARD, CAT#: 113657, LOT#: 117270; COMPREHENSIVE REVERSE CENTRAL SCREW, CAT#: 115383, LOT#: 341010; COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE, CAT# 115313, LOT#: 441280; COMPREHENSIVE LOCKING SCREW, CAT#: 180502, LOT#: 552490; COMPREHENSIVE REVERSE SHOULDER GLENOID BASEPLATE +HA, CAT#: 115330, LOT#: 596830; COMPREHENSIVE LOCKING SCREW, CAT#: 180502, LOT#: 219610; COMPREHENSIVE LOCKING SCREW, CAT#: 180500, LOT#: 970090; STN PIN THREADED TIP, CAT#: 406669, LOT#: 452690; COMPREHENSIVE REVERSE SHOULDER 9 IN STEINMANN, CAT#: 405800, LOT#: 480960; COMPREHENSIVE REVERSE 2.7 MM DIAMETER DRILL, CAT#: 405889, LOT#: 209170; COMPREHENSIVE REVERSE 3.2 MM DRILL, CAT#: 405883, LOT#: 432270.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PROVIDED X-RAYS AND OP NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. DIAGNOSIS OF FRACTURED LOCKING RINGS CONFIRMED AT REVISION. REVISION OPERATIVE NOTES STATE: HUMERAL TRAY MORRIS TAPER WAS FRACTURED. METALLOSIS WAS REMOVED. FRACTURED PORTION HAD WORN INTO BEARING. THE ROOT CAUSE WAS RELATED TO THE DESIGN OF THE DEVICE. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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

    (B)(4). THIS EVENT WAS PREVIOUSLY REPORTED TO THE FDA VIA MW5068438. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT LEFT REVERSE SHOULDER ARTHROPLASTY. APPROXIMATELY 6 YEARS LATER, THE PATIENT REPORTS THAT SOMETHING POPPED IN THE LEFT SHOULDER WHILE RAISING THE ARM, CAUSING PAIN AND LOSS OF FUNCTION. X-RAYS WERE PERFORMED AND INDICATED HUMERAL TRAY FAILURE. PATIENT WAS REVISED 2 MONTHS LATER, AND A FRACTURED LOCKING RING WAS REMOVED AT THE REVISION. NO DAMAGE OCCURRED TO THE HUMERAL STEM, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT LEFT REVERSE SHOULDER ARTHROPLASTY. APPROXIMATELY 6 YEARS LATER, THE PATIENT REPORTS THAT SOMETHING POPPED IN THE LEFT SHOULDER WHILE RAISING THE ARM, CAUSING PAIN AND LOSS OF FUNCTION. X-RAYS WERE PERFORMED AND INDICATED HUMERAL TRAY FAILURE. PATIENT WAS REVISED 2 MONTHS LATER, AND THE TAPERED PORTION OF THE HUMERAL TRAY WAS FOUND TO BE FRACTURED. BEARING WEAR IS NOTED DUE TO INTERACTION WITH FRACTURED AREA. METALLOSIS WITH METAL PARTICLES IN THE SYNOVIUM WERE ALSO NOTED AND REMOVED DURING THE REVISION. NO DAMAGE OCCURRED TO THE HUMERAL STEM, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT LEFT REVERSE SHOULDER ARTHROPLASTY. APPROXIMATELY 6 YEARS LATER, THE PATIENT REPORTS THAT SOMETHING POPPED IN THE LEFT SHOULDER WHILE RAISING THE ARM, CAUSING PAIN AND LOSS OF FUNCTION. X-RAYS WERE PERFORMED AND INDICATED HUMERAL TRAY FAILURE. NO REVISION HAS BEEN REPORTED TO DATE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279650 COMP RVS HMRL TI TRAY 44MM PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 561910

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R