BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR

    MDR report key: 6292552 · Received February 1, 2017

    Report

    Report Number
    0001825034-2017-00211
    Event Type
    Injury
    Date Received
    February 1, 2017
    Date of Event
    June 23, 2016
    Report Date
    June 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCT: COMPR NANO HMRL PPS 36 MM, US-115736 LOT #402830. VERSA-DIAL 42X21X43 HUM HEAD, CATALOG #113034 LOT #212290. SM HYBRID GLENOID BASE 4 MM, CATALOG #113952 LOT #817120. PT HYBRID GLEN POST REGENEREX, CATALOG #PT-113950, LOT #989790. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. X-RAY REVIEWER STATED "REPORTED EVENT OF "DISLOCATION/SUBLUXATION" IS CONFIRMED. ANTERIOR SUBLUXATION OF THE HUMERAL COMPONENT IS DEMONSTRATED, WHICH MAY BE ASSOCIATED WITH SUBSCAPULARIS RUPTURE OR ANTERIOR DELTOID DYSFUNCTION. DEVICE COMPONENTS APPEAR INTACT. RADIOLUCENT LINE AT THE GLENOID SCREW BONE INTERFACE MAY INDICATE GLENOID COMPONENT LOOSENING IF NEW OR PROGRESSIVE. A BONE SPUR IS PRESENT AT THE INFERIOR GLENOID RIM." DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-00211/00212/00213/00214).

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY, AND SUBSEQUENTLY NOTED PAIN BEGINNING APPROXIMATELY THREE MONTHS POST-OPERATIVELY AND CONTINUING AT TWELVE MONTH POST-OPERATIVE FOLLOW-UP. THE PATIENT ADDITIONALLY REPORTED A LACK OF RANGE OF MOTION APPROXIMATELY THREE MONTHS POST-OPERATIVELY. SUBSEQUENTLY, PATIENT REPORTED SUBLUXATION AND INSTABILITY RELATED TO CONNECTIVE TISSUE LAXITY IN THE OPERATIVE SHOULDER APPROXIMATELY TWELVE MONTHS POST-OPERATIVELY. A NERVE DEFICIT WAS ALSO NOTED AT TWELVE MONTH FOLLOW-UP, HOWEVER REPORTEDLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76260 COMPREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS NI 465300

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other