BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER

    MDR report key: 7060194 · Received November 27, 2017

    Report

    Report Number
    0001822565-2017-07984
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    October 27, 2017
    Report Date
    March 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    PK052906
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. X-RAYS REVIEWER STATED SECOND IMAGE DEMONSTRATES ANTERIOR DISLOCATION OF THE HUMERAL COMPONENT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS 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

    CMP-(B)(4). CONCOMITANT MEDICAL PRODUCTS: 00434903811, BASE PLATE UNCEMENTED, 63647115; 00434903611, GLENOSPHERE 36 MM DIAMETER, 63697037; 00434901213, HUMERAL STEM 12 MM STEM DIAMETER 130 MM STEM LENGTH, 63633322; 963203000, DEPUY HARDINGE, D16081016; 0104223030, INVERS/REVERS SCR SYST 4.5-30, 2893209; 0104223030, INVERS/REVERS SCR SYST 4.5-30, 2897333; 61971001, STRYKER ANTIBIOTIC, TDY029. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). CUSTOMER HAS BEEN 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 A PATIENT UNDERWENT AN INITIAL TOTAL LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839642 POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A 63618438

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R