BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-ANGULAR HUMERAL HEAD

    MDR report key: 6429335 · Received March 23, 2017

    Report

    Report Number
    0001825034-2017-01853
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    March 1, 2017
    Report Date
    September 22, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK032895
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED [AS IT REMAINS IMPLANTED AT THIS TIME] TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCT - MOSAIC MOD PROX HMRL SEG 80 MM, CAT#: 111003 LOT#: 329950; MOSAIC +10 MM PROXIMAL BODY, CAT#: 111001 LOT#: 303000; CPS TRANSVERSE PIN 6PK 20 MM, CAT#: 178524 LOT#: 332470; FEMALE CPS/MALE MOSAIC TPR, CAT#: CP560752 LOT#: 904870; CPS NUT CO-CR-MO ALLOY, CAT#: 178512 LOT#: 837120; CPS XS SHT SPDL W PINS 600LBF, CAT#: 178363 LOT#: 410410; DIAH SEG LOCK SCREW SET (2 QTY), CAT#: 150481 LOT#: 0000143488; CPS SHORT ANCHOR PLUG 10 MM, CAT#: 178552 LOT#: 675350; CPS TAPER LOCKING CAP / OSS SC, CAT#: 178710 LOT#: 553290. 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). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT IS CONFIRMED. DEVICE HISTORY RECORD  (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE VISUAL INSPECTION WAS NOT PERFORMED. PER SURGICAL TECHNIQUE, THE DEVICES ON THIS COMPLAINT ARE COMPATIBLE WITH ONE ANOTHER. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. X-RAY REVIEW WAS CONDUCTED. THE ROOT CAUSE WAS DETERMINED TO BE PATIENT SOFT TISSUE CONDITION. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 HAS BEEN INDICATED FOR A SHOULDER REVISION DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION FROM A PROXIMAL HUMERUS HEMI-ARTHROPLASTY DUE TO INSTABILITY CAUSED BY ROTATOR CUFF ISSUES APPROXIMATELY FIVE (5) YEARS POST-IMPLANTATION. THE PATIENT WAS CONVERTED TO A REVERSE SHOULDER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210647 BI-ANGULAR HUMERAL HEAD PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 893240

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R