BEUDAMED
    FDA Adverse Event Injury Summary report: N

    30 SILICONE PIP IMPLANT (STERILE PACKED)

    MDR report key: 4915768 · Received July 15, 2015

    Report

    Report Number
    0008031020-2015-00304
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 24, 2015
    Manufacturer
    STRYKER GMBH
    Product Code
    KYJ
    PMA / PMN Number
    K931588
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT A 30 SILICONE PIP IMPLANT (STERILE PACKED) WAS ALLEGED OF BREAKAGE AFTER SURGERY COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A PATIENT RELATED ISSUE. THE MOST LIKELY CAUSE IS EXCESSIVE PHYSICAL ACTIVITY AND/OR ABUSE. STRENUOUS LOADING, EXCESSIVE MOBILITY, AND ARTICULAR INSTABILITY ALL MAY LEAD TO ACCELERATED WEAR AND EVENTUAL FAILURE BY FRACTURE OF THE DEVICE. PATIENTS SHOULD BE MADE AWARE OF THE INCREASED POTENTIAL FOR DEVICE FAILURE IF EXCESSIVE DEMANDS ARE MADE UPON IT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY (B)(4) AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF SBI ON (B)(6) 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON (B)(6) 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PIP IMPLANT BREAK. THE IMPLANT WAS IN FOR LESS THAN 3 MONTHS. SALES REP STATED THAT PATIENT WENT IN FOR FOLLOW UP AND STATED THEY WERE FEELING GREAT AND HAD GOOD MOVEMENT AND UPON X-RAY IT WAS DISCOVERED THE IMPLANT WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PIP IMPLANT BREAK. THE IMPLANT WAS IN FOR LESS THAN 3 MONTHS. SALES REP STATED THAT PATIENT WENT IN FOR FOLLOW UP AND STATED THEY WERE FEELING GREAT AND HAD GOOD MOVEMENT AND UPON X-RAY IT WAS DISCOVERED THE IMPLANT WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459683 30 SILICONE PIP IMPLANT (STERILE PACKED) PROSTHESIS, FINGER, CONSTRAINED, POLYMER23 KYJ STRYKER GMBH 23987001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention