BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET

    MDR report key: 6530113 · Received April 28, 2017

    Report

    Report Number
    0001825034-2017-02779
    Event Type
    Injury
    Date Received
    April 28, 2017
    Date of Event
    December 1, 2016
    Report Date
    May 10, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (UDI #) - (B)(4). CONCOMITANT PRODUCT(S): CATALOG #: US115740, COMPREHENSIVE NANO, LOT # 752510. CATALOG #: NI, SIMPLEX P CEMENT, LOT # NI. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINS IMPLANTED. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02767, 02779, 02781, 02789.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: SIMPLEX P CEMENT, CAT#: NI, LOT # NI. COMPREHENSIVE NANO, CAT#: US115740, LOT # 752510. VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER, CAT#: 118001, LOT#: 085220. HYBRID GLENOID BASE, CAT#: 113956, LOT#: 900480. PT HYBRID GLENOID REGENEREX POST, CAT#: PT-113950, LOT#: 970040. ROOT CAUSE REMAINS UNDETERMINED. 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. X-RAYS WERE RECEIVED AND REVIEWED. PER THE REVIEW, NO CAUSE FOR PAIN AND NUMBNESS IS IDENTIFIED NOR ANYTHING VISUALIZED THAT WOULD CAUSE NERVE DAMAGE. OVERALL FIT, SIZE, AND ORIENTATION APPEAR UNREMARKABLE. BONE QUALITY AND PATIENT ANATOMY APPEAR UNREMARKABLE. THERE IS ADVANCED OSTEOARTHRITIS OF THE ACROMIOCLAVICULAR JOINT. ROOT CAUSE REMAINS UNDETERMINED; HOWEVER, IT WAS IDENTIFIED THAT THE PATIENT HAS CERVICAL STENOSIS WHICH MAY BE A CONTRIBUTING FACTOR TO RADIATING PAIN AND NUMBNESS. 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). 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 FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AT NIGHT AND MILD INSTABILITY NOTED AT THREE (3) MONTH POST-OPERATIVE FOLLOW-UP. ADDITIONALLY, AT ONE (1) YEAR POST-OPERATIVE FOLLOW-UP IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING WORSENING PAIN IN THEIR SHOULDER, BEGINNING NINE MONTHS POST-OPERATIVELY; SUPRASPINATUS/GREATER TUBEROSITY TENDERNESS; ACROMIOCLAVICULAR JOINT TENDERNESS; BICEPS TENDON TENDERNESS; AND IMPINGEMENT. OUTCOME OF TREATMENT IS PENDING AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AT NIGHT AND MILD INSTABILITY NOTED AT THREE (3) MONTH POST-OPERATIVE FOLLOW-UP. ADDITIONALLY, AT ONE (1) YEAR POST-OPERATIVE FOLLOW-UP IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING WORSENING PAIN IN THEIR SHOULDER, BEGINNING NINE MONTHS POST-OPERATIVELY; SUPRASPINATUS/GREATER TUBEROSITY TENDERNESS; ACROMIOCLAVICULAR JOINT TENDERNESS; BICEPS TENDON TENDERNESS; AND IMPINGEMENT. FURTHERMORE, DURING THE PATIENT'S TWO (2) YEAR POST-OPERATIVE FOLLOW-UP THE PATIENT REPORTED MILD PAIN (1 OUT OF 10), MILD INSTABILITY (0-1CM TRANSLATION), DELTOID TENDERNESS, AS WELL AS NUMBNESS ACROSS SHOULDER INTO THE DELTOID. THE PATIENT ALSO RECEIVED A DIAGNOSIS OF CERVICAL STENOSIS BUT HAS YET TO FOLLOW UP WITH A NEUROLOGIST. OUTCOME OF TREATMENT IS PENDING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312201 COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 429880

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other