BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TM SHELL WITH CLUSTER HOLES

    MDR report key: 2692977 · Received August 9, 2012

    Report

    Report Number
    1822565-2012-01694
    Event Type
    Injury
    Date Received
    August 9, 2012
    Date of Event
    July 7, 2012
    Report Date
    July 10, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: DURING THE OPERATION, A SEROMA WAS IDENTIFIED AND APPROXIMATELY 50 ML OF CLEARISH-YELLOW FLUID WAS ASPIRATED. THE REST OF THE REVISION WAS UNEVENTFUL. VERY POOR QUALITY X-RAYS WERE PROVIDED OF THE COMPONENTS PRE-REVISION. ALTHOUGH NOT CONCLUSIVE, THEY SHOWED A FEMORAL STEM THAT SEEMED SLIGHTLY VALGUS IN POSITION WITHIN THE FEMORAL CANAL AND AN ACETABULAR CUP THAT SEEMED MORE HORIZONTAL IN POSITION. THE ZIMMER STERILIZATION VENDOR PROCESSES ALL IMPLANTS TO MEET FDA REGULATIONS AND ISO STANDARDS AT A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. ZIMMER, INC., CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT UNDERWENT AN ASPIRATION DUE TO PAIN AND SWELLING TO RULE OUT INFECTION. THE PAIN AND SWELLING PROGRESSED AND THE PT'S HIP WAS REVISED. A SEROMA WAS IDENTIFIED UPON SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM TM SHELL WITH CLUSTER HOLES LZO ZIMMER, INC. 62058346

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention CAT# 00875101136, LOT#61813342, MANUFACTURED BY| MANUFACTURED BY ZIMMER, (B)(4)| BONE SCREW: CAT# 00625006535, LOT#61974181,| BONE SCREW: CAT# 00625006525, LOT# 62011525,| BONE SCREW: CAT# 00625006520. LOT# 62016786,| VERSYS FEMORAL HEAD: CAT# 00801803604,| LOT# 61928555, MANUFACTURED BY ZIMMER,| (B)(4)| MANUFACTURED BY ZIMMER, (B)(4)| ZIMMER, (B)(4)| CONTINUUM, TRILOGY IT, ALLOFIT IT POLY LINER:| MANUFACTURED BY ZIMMER, (B)(4)