BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON CR FEM COMP #4 R-CEM

    MDR report key: 8190262 · Received December 21, 2018

    Report

    Report Number
    0002249697-2018-04109
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    November 26, 2018
    Report Date
    December 21, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327040289
    PMA / PMN Number
    K141056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACK DAMAGE INVOLVING A TRIATHLON FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED BY VISUAL INSPECTION OF THE RETURNED PRODUCT. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: ONE UNIT CARTON CONTAINING ITS OUTER/ INNER BLISTER AND DEVICE WAS RETURNED FOR EVALUATION. SEVERE COMPRESSION AND INDENTATION LINES ARE VISIBLE ON THE UNIT CARTON WITH THE OPENING FLAP OUT OF SHAPE COMPLETELY. COMPRESSION AND WEAR IS ALSO VISIBLE ON THE CORNERS OF THE UNIT CARTON. THE OUTER BLISTER WAS RETURNED WITH THE TYVEK LID STILL ATTACHED. ONE SIDE FLANGE IS BROKEN AWAY FROM THE OUTER BLISTER ALLOWING THE TYVEK TO BE PEELED BACK AS IT IS STILL ATTACHED. THERE IS EVIDENCE OF A GOOD SEAL ON THE THREE REMAINING SIDES OF THE OUTER BLISTER. -CLINICIAN REVIEW: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. THE EVENT IS RELATED TO A PACKAGING ISSUE AND NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. DEVICE HISTORY REVIEW: INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSION: BASED ON THE VISUAL INSPECTION OF THE RETURNED PRODUCT THE INVESTIGATION CONCLUDED THAT THE PACKAGING DAMAGE WAS MOST LIKELY CAUSED BY INCORRECT/EXCESSIVE HANDLING PRIOR TO OPENING OF THE PRODUCT WHEREBY THE UNIT CARTON MAY HAVE BEEN COMPRESSED AND/OR DROPPED FROM A HEIGHT CAUSING THE DAMAGE TO THE CARTON. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    DURING SURGERY, THE NURSE WAS OPENING THE IMPLANTS AND NOTICED THE INNER PLASTIC BOX OF THE FEMORAL IMPLANT (B)(4) WAS DAMAGED AND THEREFORE QUESTIONED THE STERILITY. ANOTHER IMPLANT FROM CONSIGNMENT STOCK WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030142 TRIATHLON CR FEM COMP #4 R-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH CYJ2E 07613327040289

    Patients

    Seq Age Sex Outcome Treatment
    1 Other