BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL

    MDR report key: 8914981 · Received August 21, 2019

    Report

    Report Number
    0001822565-2019-03570
    Event Type
    Injury
    Date Received
    August 21, 2019
    Date of Event
    December 24, 2015
    Report Date
    August 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K002960
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:00877703601 LOT NUMBER:2767376 BRAND NAME: BIOLOX HEAD, CATALOG NUMBER:AR-182SSF LOT NUMBER: 1240438 BRAND NAME: SUTURE ANCHO, CATALOG NUMBER: 00625006525 LOT NUMBER:61999335 BRAND NAME: BONE SCREW. OPERATIVE NOTES WERE REVIEWED AND IDENTIFIED PATIENT UNDERWENT I&D DUE TO REVISION. THE PATIENT NOTED REDNESS AT THE MID-PORTION OF HIS WOUND WITH A BULLOUS FORMATION. LAB TESTS DEMONSTRATED MARKEDLY ELEVATED SEDIMENTATION RATE, NORMAL C-REACTIVE PROTEIN, CBC DEMONSTRATED ANAEMIA. BOLUS STARTED TO DRAIN AND AFTER SKIN INCISION MADE EXCISED. GROSS PURULENCE LEADING TO THE ANTERIOR FEMUR AS WELL AS THE JOINT POSTERIORLY IN A Y FASHION. FASCIA LATA HAD LARGE OPEN LESION WITH DEHISCENCE OF POSTERIOR CAPSULAR AND SHORT ER REPAIR AS WELL AS ABDUCTOR REPAIR. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. 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. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION APPROXIMATELY 40 DAYS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711515 LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL PRROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 62916914

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R