BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE

    MDR report key: 6491287 · Received April 13, 2017

    Report

    Report Number
    0001825034-2017-02526
    Event Type
    Injury
    Date Received
    April 13, 2017
    Report Date
    September 19, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCT: VERSA DIAL TAPER CATALOG#:118001 LOT#:378870 COMPREHENSIVE PRIMARY STEM CATALOG#:113652 LOT#:496560 COMPREHENSIVE REVERSE TRAY, CATALOG#: 115375, LOT#: 360190 COMPREHENSIVE REVERSE HUMERAL BEARING CATALOG#:XL-115363 LOT#:369090 COMPREHENSIVE REVERSE SHOULDER GLENOID BASEPLATE CATALOG#:115330 LOT#:422790 COMPREHENSIVE REVERSE CENTRAL SCREW CATALOG#: 115396 LOT#:424640 COMPREHENSIVE LOCKING SCREW, CATALOG#: 180500, LOT#: 770390 COMPREHENSIVE LOCKING SCREW, CATALOG#: 180502, LOT#: 568050 COMPREHENSIVE LOCKING SCREW, CATALOG#: 180503, LOT#: 770430 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. 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

    (B)(4). CUSTOMER HAS NOT YET INDICATED IF THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE DEVICE REMAINS IMPLANTED AT THIS TIME. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-02806/ MDT33098/ 1825034-2016-03470/ 1825034-2016-04831/ 0001825034-2016-02804/ 0001825034-2016-02805. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02553/ 0001825034-2017-02554/ 0001825034-2017-02555/ 0001825034-2017-02556/ 0001825034-2017-02557. MEDICAL PRODUCTS: VERSA DIAL TAPER CATALOG #:118001 LOT#:378870, COMPREHENSIVE CNTRL CATALOG #: 1153696, LOT #:424640; STEM CATALOG #:113652, LOT # :496560; TRAY, CATALOG #:115370, LOT #:UNK; HUMERAL BEARING, CATALOG #:XL-115363, LOT #:369090; VERSA DIAL TAPER CATALOG #:118001, LOT #:707740; SHOULDER GLENOID BASEPLATE, CATALOG #:115330, LOT #:422790; STEM CATALOG #:113632 LOT #:485330; COMPREHENSIVE CENTRAL SCREW, CATALOG #: 115383, LOT #:787000; HUMERAL BEARING, CATALOG #:XL-115363, LOT# :950910; REVERSE SHOULDER, CATALOG #:115310, LOT #:921470; HUMERAL BEARING, CATALOG#: XL-115363, LOT #:450680.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT IS EXPERIENCING PAIN AND HEADACHES APPROXIMATELY EIGHT MONTHS FOLLOWING REVISION SHOULDER PROCEDURE. NO REVISION PROCEDURE HAS BEEN INDICATED TO DATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271489 COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 868870

    Patients

    Seq Age Sex Outcome Treatment
    1 Other