BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA HIP SYSTEM MODULAR CERAMIC HEAD

    MDR report key: 7139560 · Received December 21, 2017

    Report

    Report Number
    0001825034-2017-11396
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    August 15, 2016
    Report Date
    March 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK051411
    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

    (B)(4). MEDICAL PRODUCT: G7 ACETABULAR SYSTEM DUAL MOBILITY ACETABULAR LINER, CATALOG#: 110024462, LOT#: 401090. 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. 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.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    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
    919198 BIOLOX DELTA HIP SYSTEM MODULAR CERAMIC HEAD PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 630110

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R