BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 46X18X53 HUMERAL HEAD

    MDR report key: 6155827 · Received December 8, 2016

    Report

    Report Number
    0001825034-2016-05100
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    September 7, 2016
    Report Date
    July 8, 2017
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 13 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." (B)(4). CONCOMITANT MEDICAL PRODUCT ¿ COMP PRIMARY STEM 8MM MINI, CATALOG#: 113628 LOT 161570; PT HYBRID GLEN POST REGENEREX, CATALOG#: PT-113950 LOT 162220, THERAPY DATE - (B)(6) 2016. (B)(4). THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-05100 / 05102 - 05103).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT: COMPREHENSIVE SHOULDER STANDARD TAPER ADAPTOR, CATALOG#: 118001, LOT#: 226600 HYBRID GLENOID BASE, CATALOG#: 113954, LOT#: 643790 COMP PRIMARY STEM 8MM MINI, CATALOG#: 113628 LOT 161570; PT HYBRID GLEN POST REGENEREX, CATALOG#: PT-113950 LOT 162220 . REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. X-RAY REVIEW STATED THAT RISK FACTORS FOR REPORTED EVENT (PAIN, IMMOBILITY AND LIMITED FUNCTION) ARE CONFIRMED. ANTERIOR SUBLUXATION OF THE HUMERAL COMPONENT IS DEMONSTRATED, WHICH MAY BE ASSOCIATED WITH SUBSCAPULARIS RUPTURE AND PAIN. LARGE OVERSIZED HUMERAL HEAD, "OVERSTUFFING" THE JOINT, MAY BE ASSOCIATED WITH INCREASED TENSION ON THE CAPSULE AND ROTATOR CUFF, DECREASED RANGE OF MOTION AND PAIN. ADDITIONALLY, DEVICE PLACEMENT APPEARS STANDARD. IT WAS ALSO STATED THAT OVERSIZED HUMERAL HEAD COMPONENT MAY BE RELATED TO THE REPORTED EVENT. 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. 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

    PATIENT UNDERWENT A RIGHT SHOULDER REVISION APPROXIMATELY 9 MONTHS POST-IMPLANTATION DUE TO A COMPLETE DEGENERATIVE TEAR OF THE SUBSCAPULARIS WHICH CAUSED PAIN, WEAKNESS AND IMMOBILITY WITH AN ONSET OF APPROXIMATELY 7 MONTHS POST-IMPLANTATION. THE PATIENT ALSO REPORTED PAIN, INSTABILITY AND IMPINGEMENT AT THREE MONTHS POST-IMPLANTATION. OPERATIVE REPORT NOTES A SYNOVIAL HEMORRHAGE, A CAPSULAR CONTRACTURE, AND A FULL THICKNESS TEAR OF THE SUBSCAPULARIS TENDON. THE HUMERAL HEAD, STANDARD TAPER ADAPTER AND GLENOID BASE COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805275 VERSA-DIAL 46X18X53 HUMERAL HEAD PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 445490

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R