BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM BEADED SIZE4 BP

    MDR report key: 3960010 · Received July 28, 2014

    Report

    Report Number
    0002249697-2014-02873
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 15, 2013
    Report Date
    July 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K051380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING A TRIATHLON BASEPLATE COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. A REVIEW OF THE PROVIDED MEDICAL RECORDS AND RADIOLOGY REPORTS BY A CLINICAL CONSULTANT INDICATED: ROOT CAUSE OF FAILURE THROUGH THE TRAUMATIC INCIDENT OF FALL FROM A FLIGHT STAIRS APPEARS THE MOST PLAUSIBLE AND PROBABLE EXPLANATION FOR THE FAILURE SCENARIO OF THIS CASE CONTRIBUTING AT FIRST TO RUPTURE OF THE MCL THAT WAS REPAIRED SURGICALLY BUT ALSO INDUCED COMPONENT INSTABILITY THAT EVOLVED SECONDARILY TO FULL-BLOWN LOOSENING WITH CLINICAL SYMPTOMS WITH MORBID OBESITY ACTING AS A SECONDARY FACTOR TO AGGRAVATE THE OVERLOAD. NO EVIDENCE FOR DEVICE-RELATED FACTORS ALTHOUGH NO DEVICES HAVE BEEN RETURNED FOR INVESTIGATION THAT MIGHT HAVE PROVIDED ADDITIONAL INSIGHT INTO POTENTIALLY RELEVANT CONTRIBUTING FACTORS. AS BASED ON CURRENTLY AVAILABLE INFORMATION, ROOT CAUSE OF FAILURE IS MOST PROBABLY THROUGH AN ADVERSE COMBINATION OF PATIENT-RELATED FACTORS REGARDING TRAUMA TO THE KNEE ARTHROPLASTY WITH ASSOCIATED MORBID OBESITY AS CO-FACTOR. BASED ON THE MEDICAL REVIEW PERFORMED THE ROOT CAUSE OF FAILURE THROUGH THE TRAUMATIC INCIDENT OF FALL FROM A FLIGHT STAIRS APPEARS THE MOST PLAUSIBLE AND PROBABLE EXPLANATION FOR THE FAILURE SCENARIO OF THIS CASE CONTRIBUTING AT FIRST TO RUPTURE OF THE MCL THAT WAS REPAIRED SURGICALLY BUT ALSO INDUCED COMPONENT INSTABILITY THAT EVOLVED SECONDARILY TO FULL-BLOWN LOOSENING WITH CLINICAL SYMPTOMS WITH MORBID OBESITY ACTING AS A SECONDARY FACTOR TO AGGRAVATE THE OVERLOAD. NO EVIDENCE FOR DEVICE-RELATED FACTORS ALTHOUGH NO DEVICES HAVE BEEN RETURNED FOR INVESTIGATION THAT MIGHT HAVE PROVIDED ADDITIONAL INSIGHT INTO POTENTIALLY RELEVANT CONTRIBUTING FACTORS. NO EVIDENCE PRESENT FOR PROCEDURE-RELATED OR DEVICE-RELATED FACTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO HAD HER KNEE REPLACED IN 2009. SOMETIME AFTER HER ORIGINAL SURGERY, THE PATIENT FELL DOWN A FLIGHTSTAIRS. HER MCL WAS TORN DURING THE FALL AND HAD TO BE REPAIRED. THE DATE OF THE MCL SURGERY IS NOT KNOWN. THE PATIENT RECENTLY PRESENTED TO DR. (B)(6) WITH LEFT KNEE PAIN. XRAYS AND A BONE SCAN WERE TAKEN OF THE LEFT KNEE. DR. (B)(6) DETERMINED FROM THE XRAY AND THE BONE SCAN THAT THE TIBIAL COMPONENT MAY HAVE BECOME UNSTABLE. HE MADE THE DECISION TO REVISE HER LEFT TOTAL KNEE. DR. (B)(6) REMOVED THE TRIATHLON CR INSERT, THE TRIATHLON CR PRESSFIT FEMUR, AND THE TRIATHLON PRESS FIT TIBIAL BASEPLATE. THE TRIATHLON PATEELA WAS DETERMINED TO BE WELL FIXED AND REMAINED IN THE PATIENT. DR. (B)(6) REVISED HER KNEE TO A TRIATHLON PS CEMENTED FEMUR, A TRIATHLON CEMENTED UNIVERSAL BASEPLATE, A 12X50MM CEMENTED STEM, AND A 4/16MM PS X3 INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439622 TRIATHLON PRIM BEADED SIZE4 BP IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH SLFCP

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention