BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLARLESS BI-METRIC POROUS STEM

    MDR report key: 6739187 · Received July 24, 2017

    Report

    Report Number
    0001825034-2017-05183
    Event Type
    Injury
    Date Received
    July 24, 2017
    Date of Event
    July 14, 2008
    Report Date
    December 16, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, (STILL IMPLANTED). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IMPLANT DATE: - INITIAL - 2008. CONCOMITANT PRODUCT(S): ¿ STAINLESS STEEL CABLE/SLEEVE COMBO, P/N 350806, L/N 790570; MODULAR HEAD COMPONENT, P/N 163670, L/N 561090; RING LOC ACETABULAR LINER, P/N 11-105924, L/N 097620; COLLARLESS BI-METRIC POROUS STEM, P/N X11-180313, L/N 340400; RINCLOC AND QUICK CONNECT DRILL BIT, P/N 31-323230, L/N 016260; RANAWAT/BURSTEIN ACETABULAR SHELL, P/N 11-106054, L/N 7751510; TI LOW PROFILE SCREW, P/N 106537, L/N 016260. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-05179, 0001825034-2017-05180, 0001825034-2017-05181, 0001825034-2017-05183, 0001825034-2017-05184, 0001825034-2017-05185, 0001825034-2017-05182. STILL IMPLANTED.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED REVISION OP NOTES. REVIEW OF THE REVISION OP NOTES SHOW PATIENT UNDERWENT A REVISION WHERE STEM AND HEAD WERE REMOVED AND REPLACED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED 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 THE ASSOCIATED 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS ¿ TI LOW PROFILE SCREW P/N 103537 L/N 132610; RINGLOC ACETABULAR DRILL BIT P/N 31-323230 L/N 016260; COCR MODULAR HEAD P/N 163674 P/N 570550; ARCOM RINGLOC LINER P/N 11-105924 L/N 097620; BI-METRIC POR NECK P/N X11-180313 L/N 340400; RINGLOC SHELL P/N 11-106054 L/N 775150. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTION WAS CORRECTED: EVENT IS NOT A MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD AN INITIAL PROCEDURE NINE YEARS AGO AND EXPERIENCING PAIN THROUGH THE RIGHT LEG. PATIENT IS UNAWARE IF THE SURGERY WAS PERFORMED CORRECTLY WHEN INSTALLING THE HIP. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS REVISED ONE MONTH POST IMP-PLANTATION. THE HEAD AND STEM WERE REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS REVISED ONE MONTH POST IMP-PLANTATION DUE TO IMPLANT FRACTURE. THE HEAD AND STEM WERE REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT FRACTURED THE PROXIMAL FEMUR FOUR DAYS POST IMPLANTATION. PATIENT WAS PLACED ON SKELETAL TRACTION WITH CABLES FOR HEALING. APPROXIMATELY 21 DAYS LATER THE HEAD AND STEM WERE REVISED AND NEW CABLES WERE PUT INTO PLACE. APPROXIMATELY 30 DAYS POST-IMPLANTATION PATIENT EXPERIENCED GASTROINTESTINAL COMPLICATIONS AND WAS PLACED ON MEDICATION. PATIENT ALSO RECEIVED A BLOOD TRANSFUSION DUE TO LOW HEMOGLOBIN AND HEMATOCRIT LEVELS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518793 COLLARLESS BI-METRIC POROUS STEM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 340400

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R