BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TM SHELL WITH CLUSTER HOLES

    MDR report key: 6757759 · Received August 1, 2017

    Report

    Report Number
    0001822565-2017-05213
    Event Type
    Injury
    Date Received
    August 1, 2017
    Date of Event
    July 5, 2017
    Report Date
    June 6, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK151448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF SURGICAL NOTES. SURGICAL NOTES SHOWS THAT THE CUP WAS NOT SEATED WELL AND THIS WAS CONFIRMED THROUGH AN X-RAY. THE SURGEON REMOVED THE LINER, IMPACTED THE CUP AGAIN WITH LESS ANTEVERSION AND IT WAS SEATED WELL. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: BIOLOX DELTA CERAMIC FEMORAL HEAD, P/N 00877503601, L/N 2864753; AVENIR MUELLER STEM, P/N 0106010002, L/N 2870991; LINER NETURAL, P/N 00875101036, L/N 63613783.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A TOTAL HIP ARTHROPLASTY, RADIOGRAPHY REVEALED THE ACETABULAR CUP WAS NOT FULLY SEATED. THE PATIENT WAS REOPENED, THE CUP WAS REPOSITIONED, AND THE ACETABULAR LINER, FEMORAL STEM AND HEAD WERE REMOVED AND REPLACED. 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 THAT AFTER A TOTAL HIP ARTHROPLASTY, RADIOGRAPHY REVEALED THE ACETABULAR CUP WAS NOT FULLY SEATED. THE PATIENT WAS REOPENED, THE CUP WAS REPOSITIONED, AND THE ACETABULAR LINER, AND HEAD WERE REMOVED AND REPLACED. THE SHELL WAS NOT REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538513 CONTINUUM TM SHELL WITH CLUSTER HOLES PROSTHESIS, HIP LPH ZIMMER, INC. N/A 63660743

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention