BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM STANDARD

    MDR report key: 6681310 · Received June 30, 2017

    Report

    Report Number
    0001825034-2017-04432
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    May 30, 2017
    Report Date
    August 21, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    Z-1103-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. A RADIOLOGIST REVIEWED PROVIDED X-RAYS AND NOTED NO HARDWARE FAILURE AND AN OVERALL FIT AND ALIGNMENT OF THE IMPLANTS, OSTEOPENIA, AND NO SIGNS OF LOOSENING, WEAR, OR RADIOLUCENCY. 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. 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 THIS PART AND LOT NUMBER ARE ASSOCIATED WITH A RECALL. THE RECALL CONCERNS FATIGUE FRACTURE OF THE COMPREHENSIVE REVERSE HUMERAL TRAY. FRACTURE HAS BEEN NOTICED TO OCCUR AROUND THE TAPER TRAY JUNCTION. UNSPECIFIED PRINT DIMENSION TRAY THICKNESS AND RADIUS MAY CONTRIBUTE TO DEVISE FATIGUE FAILURE. 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). CONCOMITANT DEVICES - COMPREHENSIVE REVERSE GLENOID BASEPLATE CATALOG #: 115330 LOT #: 680580, COMPREHENSIVE REVERSE 36MM GLENOSPHERE CATALOG #: 115313 LOT #: 741400, COMPREHENSIVE REVERSE 17MM PRIMARY STEM CATALOG #: 113657 LOT #: 715500, COMPREHENSIVE REVERSE ARCOM RETENTIVE HUMERAL BEARING CATALOG #: XL-115365 LOT #: 382310, COMPREHENSIVE SHOULDER STANDARD TAPER ADAPTOR CATALOG #: 118001 LOT #: 037680, NON-LOCKING SCREW 4.75MM X 15MM CATALOG #: 180507 LOT #: 268880, NON-LOCKING SCREW 4.75MM X 20MM CATALOG #: 180508 LOT #: 436550, NON-LOCKING SCREW 4.75MM X 25MM CATALOG #: 180509 LOT #: 436580, NON-LOCKING SCREW 4.75MM X 30MM CATALOG #: 180510 LOT #: 436610, FIXED LOCKING SCREW 4.75 X 25MM CATALOG #: 180502 LOT #: 851920, COMPREHENSIVE REVERSE CENTRAL SCREW 6.5MM X 40MM CATALOG #: 115384 LOT #: 732650, COMPREHENSIVE REVERSE STEINMANN PIN CATALOG #: 405800 LOT #: 974150, COMPREHENSIVE REVERSE 3.2MM DIAMETER DRILL CATALOG #: 405883 LOT #: 419260, COMPREHENSIVE REVERSE 2.7MM DIAMETER DRILL CATALOG #: 405889 LOT #: 125230. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY REVISION SURGERY DUE TO ONSET OF PAIN FOLLOWING A FALL. IT WAS FURTHER REPORTED THAT THE PATIENT'S HUMERAL TRAY TRUNNION HAD FRACTURED AS A RESULT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY REVISION DUE TO AN ALLEGATION THAT THE DEVICE MAY BE RECALLED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION, BUT NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461521 COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM STANDARD PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 839150

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R SEE H10 NARRATIVE