BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY 36MM RLC LNR MROM SZ25

    MDR report key: 7752582 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-06056
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    September 6, 2013
    Report Date
    September 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK070364
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 650-1057, CER BIOLOXD OPTION HD 36MM, 555010; 13-104160, M/H 3HOLE RLC SHL NRS 60MM/L25, 921570; 103531, TI LOW PROFILE SCREW 6.5X20MM, 268920; 103533, TI LOW PROFILE SCREW 6.5X30MM, 102860; 51-107160, TPRLC 133 MP TYPE1 PPS HO 16.0, 2870047; 650-1064, CER OPTION TYPE 1 TPR SLEVE -6, 761800. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-06054. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, [DISCARDED]. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09057 AND 0001825034-2018-09058. REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OP NOTES PROVIDED. REVIEW OF THE REVISION OP NOTES STATES THAT THE REVISION PERFORMED DUE TO PERIPROSTHETIC INFECTION, ASPIRATION OF THE AREA OF THE ABSCESS REVEALED 104,300 WHITE BLOOD CELLS WITH 98% NEUTROPHILS (UNKNOWN DATE OF THIS ASPIRATION AND FINDING, BUT STATED IN OPERATIVE REPORT). COPIOUS AMOUNTS OF PURULENT MATERIAL WAS ENCOUNTERED AND EVACUATED THAT DID DISRUPT THE PATIENT'S FASCIA. INVOLVEMENT WAS CONFIRMED WITH METHYLENE BLUE. HETEROTOPIC OSSIFICATION WAS ALSO NOTED AS AN INCIDENTAL FINDING. FEMORAL HEAD WAS REMOVED AS WELL AS THE ACETABULAR LINER AND REPLACED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 PATIENT'S HIP WAS PRESENTED WITH SWELLING THREE MONTHS POST IMPLANTATION AND UNDERWENT REVISION DUE TO PERIPROSTHETIC INFECTION. CULTURES REVEALED STREPTOCOCCUS, BETA HEMOLYTIC. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S HIP WAS PRESENTED WITH SWELLING THREE MONTHS POST IMPLANTATION AND UNDERWENT REVISION DUE TO PERIPROSTHETIC INFECTION. CULTURES REVEALED STREPTOCOCCUS, BETA HEMOLYTIC. HETEROTOPIC OSSIFICATION WAS ALSO IDENTIFIED AFTER REMOVAL OF THE LINER DURING THE REVISION PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594307 EPOLY 36MM RLC LNR MROM SZ25 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 825870

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R