BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM NON-FLARED ONE-PIECE CUP 39MM I.D. X 52MM O.D / POROUS COATED

    MDR report key: 6150858 · Received December 7, 2016

    Report

    Report Number
    0001825034-2016-05070
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    October 25, 2016
    Report Date
    June 5, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S): - BI-METRIC/X POR NC LAT 12X140 / PN X11-180312 / LN 910540, M2A 38MM MOD HD+6MM NK NO SKRT / PN 11-173664 / LN 483210. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    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 THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-05070 / 05071).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 11 YEARS POST-IMPLANT DUE TO ACETABULAR CUP LOOSENING.

    Description of Event or Problem · 1

    A REVISION PROCEDURE HAS BEEN INDICATED DUE TO CUP LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803622 M2A 38MM NON-FLARED ONE-PIECE CUP 39MM I.D. X 52MM O.D / POROUS COATED PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 093070

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R