BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 ACETABULAR SYSTEM DUAL MOBILITY ACETABULAR LINER NEUTRAL 40MM D

    MDR report key: 6063082 · Received October 28, 2016

    Report

    Report Number
    0001825034-2016-04307
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    August 15, 2016
    Report Date
    December 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    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 THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (B)(4). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, ¿LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION, AND/OR EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY¿

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: G7 ACETABULAR SCREW, CATALOG#: 010000998, LOT#: 3801672; G7 ACETABULAR SCREW, CATALOG#: 010000997, LOT#: 3753689; G7 ACETABULAR SCREW, CATALOG#: 010000999, LOT#: 3787070; G7 ACETABULAR SCREW, CATALOG#: 010000998, LOT#: 3797747; BIOLOX DELTA HIP SYSTEM MODULAR CERAMIC HEAD, CATALOG#: 12-115109, LOT#: 630110; G7 OSSEO TI 3 HOLE SHELL, CATALOG#: 110010243, LOT#: 3795520; ACT ARCTIC E1 HIP BEARING, CATALOG#: EP-200146, LOT#: 678440; TAPERLOC 133 FP TYPE1 PPS, CATALOG#: 51-100080, LOT#: 3755902. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS AND OPERATIVE NOTES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-04307, 11395, 11396.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MIGRATION AND MALALIGNMENT OF THE DUAL MOBILITY LINER WERE NOTED ON RADIOGRAPHS TEN DAYS POST-IMPLANTATION. NO REVISION PROCEDURE HAS BEEN REPORTED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED APPROXIMATELY 3 MONTHS POST-OPERATIVELY DUE TO MIGRATION AND MALALIGNMENT OF THE DUAL MOBILITY LINER. MALALIGNMENT/MIGRATION WERE INITIALLY NOTED ON RADIOGRAPHS TEN DAYS POST-IMPLANTATION. IN INITIAL OPERATIVE NOTES, SURGEON CLEARLY STATES THAT THERE IS A POSSIBILITY OF NEEDING A HEAD/LINER EXCHANGE IN FUTURE IF POSITION OF LINER CHANGES OR SYMPTOMS PRESENT FROM THE HIP. FROM THE REVISION OPERATIVE REPORT: PATIENT HAD SIGNIFICANT TENDINOSIS AND PARTIAL FRAYING. THERE WAS SIGNIFICANT METALLOSIS IN THE HIP JOINT FROM DISPLACEMENT OF METAL LINER FROM THE CUP. DUAL MOBILITY HEAD WAS REMOVED. TRUNNION WAS NOTED TO BE MILDLY SCRATCHED WITH STEM WELL FIXED. ONE OF THE SCREWS WAS PROMINENT IN THE SHELL AND WAS MOST LIKELY WAS THE REASON FOR DISPLACEMENT OF THE LINER, ACCORDING TO SURGEON. THIS SCREW WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715365 G7 ACETABULAR SYSTEM DUAL MOBILITY ACETABULAR LINER NEUTRAL 40MM D PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 401090

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R