BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR BEADED FEM #5R

    MDR report key: 5196179 · Received November 2, 2015

    Report

    Report Number
    0002249697-2015-03560
    Event Type
    Injury
    Date Received
    November 2, 2015
    Date of Event
    October 6, 2015
    Report Date
    October 6, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING A TRIATHLON FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: THE RETURNED FEMORAL COMPONENT HAS EVIDENCE OF A VERY SMALL AMOUNT FIBROUS TISSUES INTERFACING ON THE DISTAL BEADED SURFACE. THERE ARE NO CLEAR SIGNS OF ANY BONY FIXATION. THE ANTERIOR TIP HAS SEVERAL DENTS THAT CAN BE MOST LIKELY ATTRIBUTED TO DAMAGE DURING THE EXPLANTATION PROCESS. THE SUPERIOR CONDYLE SURFACES HAVE SOME MILD ABRASIVE WEAR THAT IS CONSISTENT WITH IN VIVO USE. THE DEVICE IS OTHERWISE UNREMARKABLE. -MEDICAL RECORDS RECEIVED AND EVALUATION: MEDICAL REVIEW INDICATED; INTERFACIAL BONE DEFECT CONDITIONS WERE CREATED DURING SURGICAL PREPARATION WHILE USING POROUS BEADED DEVICES THAT HAVE SUBOPTIMAL PROPERTY TO COMPENSATE FOR SUCH ISSUES LEADING TO DEVICE LOOSENING REQUIRING REVISION SURGERY. THE SURGEON IS RESPONSIBLE FOR OPTIMAL COMPONENT CHOICE GIVEN THE IMPLANTATION CONDITIONS IN THE PATIENT. THE INTERFACIAL BONE CONTACT DEFECT CONDITIONS ARE CAUSED BY SURGICAL TECHNIQUE EVEN THOUGH UNAVOIDABLE GIVEN TODAY¿S STATE OF TECHNOLOGY WITH IMPLANTATION. DEVICES WITH A HIGHER DEGREE OF SURFACE BIOACTIVITY ARE AVAILABLE TO COMPENSATE FOR SUCH CONDITIONS. THERE ARE NO DEVICE-RELATED ASPECTS HERE BECAUSE THE BEHAVIOR OF THE DEVICES IS IN LINE WITH THEIR EXPECTED BEHAVIOR AS FURTHER SUPPORTED BY THE EXPLANT PICTURES THAT CONFIRM AN ALMOST PRISTINE APPEARANCE INCLUDING THE BEARING INSERT. THIS PI CASE IS NOT DEVICE-RELATED. -DEVICE HISTORY REVIEW: DHR REVIEW FOR THE REPORTED LOT DETERMINED THAT THE DEVICE WAS MANUFACTURED AND PACKED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW CONFIRMED THAT THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: VISUAL INSPECTION IDENTIFIED A VERY SMALL AMOUNT OF FIBROUS TISSUES INTERFACING ON THE DISTAL BEADED SURFACE AND NO CLEAR SIGN OF ANY BONY FIXATION. MEDICAL REVIEW INDICATED THAT INTERFACIAL BONE DEFECT CONDITIONS WERE CREATED DURING SURGICAL PREPARATION WHILE USING POROUS BEADED DEVICES THAT HAVE SUBOPTIMAL PROPERTY TO COMPENSATE FOR SUCH ISSUES LEADING TO DEVICE LOOSENING REQUIRING REVISION SURGERY. THE SURGEON IS RESPONSIBLE FOR OPTIMAL COMPONENT CHOICE GIVEN THE IMPLANTATION CONDITIONS IN THE PATIENT. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE SURGEON OF THE HOSPITAL THAT 1 YEAR AFTER INITIAL SURGERY, THE IMPLANT HAS NOT CONNECTED TO THE BONE.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE SURGEON OF THE HOSPITAL THAT 1 YEAR AFTER INITIAL SURGERY, THE IMPLANT HAS NOT CONNECTED TO THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725061 TRIATHLON CR BEADED FEM #5R PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH EJH9L

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention