BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR

    MDR report key: 6531903 · Received April 28, 2017

    Report

    Report Number
    0001825034-2017-02926
    Event Type
    Injury
    Date Received
    April 28, 2017
    Date of Event
    January 1, 2014
    Report Date
    August 4, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT : EXACT EVENT DATE IS UNKNOWN, HOWEVER WE KNOW THE ARTHOSCOPIC SURGERY TOOK PLACE IN (B)(6) 2014 AND THE GRAFT PATCH TOOK PLACE IN (B)(6) 2014. CONCOMITANT MEDICAL DEVICES: COMP PRIMARY STEM, CATALOG#:113668, LOT#044560; COBALT-G HV BONE C, CATALOG#:402433, LOT#:003990; OPTIVAC TOTAL HIP, CATALOG#:417000, LOT#:608885; SMALL DIAMETER CEM, CATALOG#:414990, LOT#:211160; INTRAMEDULLARY PLU, CATALOG#:130609, LOT#:013650; SMALL DIA CEMENT P, CATALOG#:414995, LOT#:200240; IMPLANTATION KIT, CATALOG#:999881, LOT#:999999; MISCELLANEOUS, CATALOG#:999996, LOT#:999999; VERSA-DIAL 42X18X46 HUM HEAD, CATALOG#:113032, LOT#:394630. CUSTOMER HAS NOT INDICATED WHETHER OR NOT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AFTER THE REVISION SURGERY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02912, 0001825034-2017-02913, 0001825034-2017-02931.

    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 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 IS REPORTED THAT THE PATIENT INITIALLY UNDERWENT A RIGHT SHOULDER HEMI-ARTHROPLASTY. APPROXIMATELY FOUR YEARS POST-OPERATIVELY, THE PATIENT UNDERWENT ARTHOSCOPIC SURGERY AND DEBRIDEMENT PROCEDURE DUE TO A ROTATOR CUFF TEAR. OPERATIVE NOTES RECEIVED, CONFIRM THE RECONSTRUCTED ROTATOR CUFF HAD RUPTURED. FURTHERMORE, APPROXIMATELY ONE MONTH LATER THE PATIENT UNDERWENT AN ALLOGRAFT RECONSTRUCTION AND AUGMENTATION DUE TO ROTATOR CUFF TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311954 VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 179280

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| R