BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RNGLC 32MM CONST 10DG LNR SZ14

    MDR report key: 5619501 · Received April 29, 2016

    Report

    Report Number
    0001825034-2016-01411
    Event Type
    Injury
    Date Received
    April 29, 2016
    Date of Event
    July 28, 2016
    Report Date
    June 28, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PCUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO CORRECT INFORMATION.

    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DEVICE CODE - UNKNOWN. PRODUCT IDENTIFICATION IS UNCERTAIN THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - CP161857; LOT NUMBER - 787250; EXPIRATION DATE - JUL 31, 2014; MANUFACTURE DATE ¿ AUG 27, 2009. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - CP161897; LOT NUMBER - 181440; EXPIRATION DATE - JUL 31, 2014; MANUFACTURE DATE ¿ JUL 6, 2009. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-01410 & 01411). PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY 7 YEARS POST-IMPLANTATION DUE TO POLY WEAR. DURING THE PROCEDURE, THE TIBIAL BEARING WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY 7 YEARS POST-IMPLANTATION DUE TO WEAR OF THE ACETABULAR LINER. DURING THE PROCEDURE, THE ACETABULAR LINER WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE APPROXIMATELY THIRTY YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2009 FOR ACETABULAR LINER WEAR. A SECOND REVISION PROCEDURE HAS BEEN INDICATED DUE TO AN UNKNOWN REASON; HOWEVER, NO SECOND REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276815 RNGLC 32MM CONST 10DG LNR SZ14 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 787250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R