BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM FEMORAL HEAD

    MDR report key: 1980199 · Received February 1, 2011

    Report

    Report Number
    2648920-2011-00001
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    August 25, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE FOLLOWING MECHANISMS MAY CONTRIBUTE TO INSTABILITY OR DISLOCATION: UNSATISFACTORY PLACEMENT OF THE COMPONENT PARTS. EXTENT OR COMPONENT STABILITY. IF COMPONENTS THAT WERE NOT MATCHED FOR THE PT REQUIREMENTS ARE USED (I.E. IMPROPER OFFSET, FEMORAL HEAD SIZE), THIS MAY INCREASE THE INSTABILITY OF THE JOINT, WHICH MAY LEAD TO DISLOCATION. EXTENT OF SOFT TISSUE TENSION. PT BEHAVIOR. IN THIS CASE, THE REPORTED TORN AND LOOSE JOINT CAPSULE, COUPLED WITH THE DEGREE OF ANTEVERSION THE SHELL/LINER CONSTRUCT WAS POSITIONED MAY HAVE CONTRIBUTED TO THE INSTABILITY/DISLOCATION EXPERIENCED. GIVEN THE INFO PROVIDED, A DEFINITIVE CAUSE CANNOT BE DETERMINED WITH CERTAINTY. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR INSTABILITY AND DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM FEMORAL HEAD KNEE PROSTHESIS LPH ZIMMER 61452233

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention SHELL WITH CLUSTER HOLES| MFG AT ZIMMER (B)(4)| CATALOG #00875705601, LOT # 61499710| MFG AT (B)(4)| CONTINUUM ACETABULAR SYSTEM TRABECULAR METAL| CATALOG #00875201236, LOT #61437371| CONTINUUM TRILOGY IT ALLOFIT POLY LINER