BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTRAINED HEAD-6MM

    MDR report key: 4330526 · Received December 15, 2014

    Report

    Report Number
    0001825034-2014-09043
    Event Type
    Injury
    Date Received
    December 15, 2014
    Date of Event
    September 15, 2014
    Report Date
    October 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWZ
    PMA / PMN Number
    PK030047
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED COMPONENT FOUND EVIDENCE TO SUGGEST AN EXTERNAL FORCE LEADING TO NORMAL DESIGN SPECIFIED DISLOCATION. THERE IS NO INDICATION WITH THE INFORMATION AVAILABLE THAT THERE IS ANY NON-CONFORMANCE WITH THE COMPONENTS AS MANUFACTURED.

    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: ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS.¿ DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS. THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08786 & 08799 / 08800 & 09041 / 09043).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). CONCOMITANT PRODUCTS- ECHO FEMORAL 12X14 CATALOG 192012 LOT 963430; TI LOW PROFILE SCREW CATALOG 103532 LOT 905450; REGENEREX 58MM ACETABULAR SHELL CATALOG PT-116058 LOT 516300; TI LOW PROFILE SCREW CATALOG 103531 LOT 016450; FREEDOM LINER CATALOG 11-107423 LOT 599550. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. VISUAL INSPECTION OF THE RETURNED COMPONENT FOUND EVIDENCE TO SUGGEST AN EXTERNAL FORCE LEADING TO NORMAL DESIGN SPECIFIED DISLOCATION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2014 AND (B)(4) 2014 DUE TO DISLOCATION. PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6 ) 2014 DUE TO RECURRENT DISLOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A THIRD RIGHT HIP REVISION PROCEDURE APPROXIMATELY THREE MONTHS AFTER THE SECOND, AGAIN DUE TO RECURRENT DISLOCATION. THE FEMORAL HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821540 FREEDOM CONSTRAINED HEAD-6MM PROSTHESIS, HIP KWZ BIOMET ORTHOPEDICS N/A 700410

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R