BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANAWAT/BURSTEIN ACETABULAR SHELL 54MM POROUS COATED

    MDR report key: 5908337 · Received August 26, 2016

    Report

    Report Number
    0001825034-2016-03321
    Event Type
    Injury
    Date Received
    August 26, 2016
    Date of Event
    April 20, 2010
    Report Date
    July 27, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK050124
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    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 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 3 OF 9 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03321 / 03322 / 03323 / 03324 / 03325 / 03326 / 03327 / 03330 AND 1825034-2016-01224). DEVICE LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL AND CORRECTED INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT PRODUCTS: RINGLOC ACETABULAR LINER: CATALOG#: EP-105894, LOT#: 383410. FEMORAL HEAD: CATALOG#: 11-363660, LOT#: 924550. ARCOS DISTAL FEMORAL STEM: CATALOG#: 11-300515, LOT#: 783660. ARCOS PROXIMAL FEMORAL STEM: CATALOG#: 11-301201, LOT#: 004570. LOW PROFILE SCREW: CATALOG#: 103538, LOT#: 296140. LOW PROFILE SCREW: CATALOG#: 103535, LOT#: 220290. LOW PROFILE SCREW: CATALOG#: 103537, LOT#: 912970. LOW PROFILE SCREW: CATALOG#: 103533, LOT#: 587650.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A HIP ARTHROPLASTY AND APPROXIMATELY 15 DAYS POST-IMPLANTATION, THE ACETABULAR CUP WAS REMOVED AND RE-IMPLANTED DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560914 RANAWAT/BURSTEIN ACETABULAR SHELL 54MM POROUS COATED PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 383650

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R