BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT SPS

    MDR report key: 3082063 · Received April 29, 2013

    Report

    Report Number
    1020279-2013-00232
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS RETURNED AND EVALUATED. UPON VISUAL EXAMINATION, THE PATELLA COMPONENT SHOWED DEFORMATION ON THE ARTICULATING SURFACE. THERE WAS CEMENT ADHERED TO THE BACKSIDE POCKET OF THE PATELLA COMPONENT THAT DID NOT BECOME DISLODGED WITH THE APPLICATION OF FORCE. DISCOLORATION DUE TO THE ABSORPTION OF BIOLOGICAL FLUID WAS ALSO OBSERVED. THE DEFORMATION LISTED ABOVE COULD HAVE ATTRIBUTED TO THE REPORTED IMPLANT LOOSENING. A REVIEW OF COMPLAINT HISTORY REVEALED A LIMITED NUMBER OF COMPLAINTS FOR THIS DEVICE/ FAILURE MODE. NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED; THEREFORE; FIT AND ORIENTATION COULD NOT BE EVALUATED. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING OR MATERIAL ABNORMALITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS. THIS INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO LOOSENING OF THE PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185748 IMPLANT SPS GEN II 7.5MM RESUR PAT 32MM JWH SMITH & NEPHEW, INC. 11AM13727

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention