BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGEN/RNGLC+ MULTI 64MM SZ 26

    MDR report key: 3770592 · Received April 24, 2014

    Report

    Report Number
    0001825034-2014-03249
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    November 9, 2009
    Report Date
    January 12, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK070369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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. THIS REPORT IS NUMBER 3 OF 12 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00816-3 / 2014-03248-2 / 2014-03249-3 / 2014-03250-3 / 03251-3 / 2014-03252-2 / 2014-03253-2 / 2014-03254-2 / 2014-03255-2 / 2014-03256-2 / 2014-3261-2 / 2016-00329).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 3 OF 11 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00816-2 / 03248-1 / 03249-2 / 03250-2 / 03251-2 / 03252-1 / 03253-1 / 03254-1 / 03255-1 / 03256-1 / 03261-1).

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION." THIS REPORT IS NUMBER 3 OF 11 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-00816 & 03248 / 03256 & 03261).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REPORT IS A DUPLICATE OF 1825034-2010-00544 / 00551.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 1992. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2008 DUE TO POLY WEAR, OSTEOLYSIS AND PAIN. IT WAS FURTHER REPORTED PATIENT UNDERWENT A RADICAL DEBRIDEMENT PROCEDURE ON (B)(6) 2009 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2010 DUE TO DISLOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6) 1992. PATIENT UNDERWENT A RIGHT REVISION PROCEDURE ON (B)(6) 2008 DUE TO POLY WEAR, OSTEOLYSIS AND PAIN. DURING THE PROCEDURE, THE HEAD AND ACETABULAR COMPONENTS WERE REMOVED AND REPLACED. IT WAS FURTHER REPORTED PATIENT UNDERWENT A RIGHT RADICAL DEBRIDEMENT PROCEDURE ON (B)(6) 2009 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER. PATIENT WAS REIMPLANTED ON THE RIGHT SIDE ON (B)(6) 2009. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT REVISION ON (B)(6) 2010 DUE TO PAIN, RECURRENT DISLOCATION AND LEG LENGTH SHORTENING. DURING THE PROCEDURE, THE LINER AND HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTED PATIENT UNDERWENT A LEFT REVISION ON (B)(6) 2003 DUE TO POLY WEAR. PATIENT UNDERWENT ANOTHER LEFT REVISION ON (B)(6) 2004 DUE TO UNKNOWN MECHANICAL COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 1992. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2008 DUE TO POLY WEAR, OSTEOLYSIS AND PAIN. IT WAS FURTHER REPORTED PATIENT UNDERWENT A RADICAL DEBRIDEMENT PROCEDURE ON (B)(6) 2009 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER. PATIENT WAS REIMPLANTED ON (B)(6) 2009. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2010 DUE TO PAIN AND RECURRENT DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250184 REGEN/RNGLC+ MULTI 64MM SZ 26 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 519630

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R