BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI LENGTH SHOULDER STEM

    MDR report key: 6465117 · Received April 6, 2017

    Report

    Report Number
    0001825034-2017-02420
    Event Type
    Injury
    Date Received
    April 6, 2017
    Date of Event
    October 1, 2016
    Report Date
    May 26, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT IS STILL IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 13 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2016-03656/ 0001825034-2017-02414/ 0001825034-2017-02416/ 0001825034-2017-02417/ 0001825034-2017-02418/0001825034-2017-02419/0001825034-2017-02421/0001825034-2017-02422/0001825034-2017-02423.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT - VERSA-DIAL 42X18X26 HUMERAL HEAD, CATALOG#: 113032, LOT#: 620590 ; VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER, CATALOG#: 118001, LOT#: 115820; MD HYBRID GLENOID BASE 4 MM, CATALOG#: 113954, LOT#: 696930; PT HYBRID GLENOID POST REGENEREX, CATALOG#: PT-113950, LOT#: 052420. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY TWENTY-ONE MONTHS POST-OPERATIVELY, THE PATIENT REPORTEDLY EXPERIENCED ONSET OF NEW PAIN AND DIFFICULTY WITH OVERHEAD ACTIVITY/MOVEMENT. FURTHERMORE, AT TWO YEAR POST-OPERATIVE FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT HAD CONTINUED PAIN, ACROMIOCLAVICULAR JOINT TENDERNESS, AND A "TWINGE" SENSATION AFTER LONG PERIODS OF HOLDING THEIR ARMS UP. NO REVISION HAS BEEN INDICATED TO DATE, AS THE ISSUE IS BEING MONITORED AND OUTCOME IS PENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY TWENTY-ONE MONTHS POST-OPERATIVELY, THE PATIENT REPORTEDLY EXPERIENCED ONSET OF NEW PAIN AND DIFFICULTY WITH OVERHEAD ACTIVITY/MOVEMENT. FURTHERMORE, AT TWO YEAR POST-OPERATIVE FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT HAD CONTINUED PAIN, ACROMIOCLAVICULAR JOINT TENDERNESS, ANTERIOR APPREHENSION, AND A "TWINGE" SENSATION AFTER LONG PERIODS OF HOLDING THEIR ARMS UP. NO REVISION HAS BEEN INDICATED TO DATE, AS THE ISSUE IS BEING MONITORED AND OUTCOME IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247841 COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI LENGTH SHOULDER STEM PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 503990

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other