BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 2. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM

    MDR report key: 9328746 · Received November 15, 2019

    Report

    Report Number
    0002249697-2019-03770
    Event Type
    Injury
    Date Received
    November 15, 2019
    Date of Event
    August 31, 2017
    Report Date
    January 15, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327027068
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING INFECTION INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS CONFIRMED VIA MEDICAL REVIEW. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED. -CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT STATED THE FOLLOWING COMMENT: POST SECOND KNEE REVISION SURGERY IN (B)(6)2017 , PROBLEMS DID UNFORTUNATELY NOT DISAPPEAR. EARLY POSTOP X-RAYS DID REPORT ¿NEAR ANATOMIC¿ ALIGNMENT OF COMPONENTS. AT 4-MONTHS FU, ON (B)(6)2017 , PATIENT REPORTED ANTERIOR KNEE PAIN AROUND THE RATHER PROTRUDING TIBIAL TUBERCLE SCREW. KNEE ROM WAS REPORTED AS AN ADEQUATE 0° -120°. X-RAYS REPORTED MIGRATION OF THE TIBIAL TUBERCLE SCREW ON (B)(6)2017 . WITH LOCAL PERSISTENT PAIN AROUND THE TIBIAL TUBERCLE SCREW, IT WAS DECIDED TO REMOVE THIS SCREW AND AS SUCH WAS PERFORMED ON (B)(6)2017 . BACTERIAL CULTURES OF THE WOUND AROUND THE SCREW DID RESULT IN CULTURE OF METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). ANAEROBIC CULTURES WERE NEGATIVE. EARLY FU CONFIRMED ADEQUATE WOUND HEALING WITH PAIN RELIEF ALTHOUGH PAIN DID SHIFT NOW MORE TO BOTH HIPS. X-RAYS OF THE HIPS DID REVEAL HOWEVER ONLY MINIMAL HIP OA. X-RAYS OF THE RIGHT KNEE DID NOT SHOW ANY CHANGE IN COMPONENT POSITION. PHYSICAL THERAPY AND PAIN MEDICATION WERE REQUIRED TO ADDRESS THE COMPLAINTS. IT SHOULD BE NOTED THAT THE SCREW WITH SPIKE WASHER INVOLVED DURING THE REMOVAL PROCEDURE IN AUG 2017 WHERE NOT STRYKER DEVICES AS MANUFACTURED BY SYNTHES BUT STILL MAY ADD TO THE COMPLEXITY OF THE CASE AND THE POTENTIAL FOR LEGAL OR LITIGATION CONSEQUENCES. -DEVICE HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS NOT PROVIDED. -COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS NOT PROVIDED. CONCLUSION: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT STATED THE FOLLOWING COMMENT: POST SECOND KNEE REVISION SURGERY IN(B)(6)2017 , PROBLEMS DID UNFORTUNATELY NOT DISAPPEAR. EARLY POSTOP X-RAYS DID REPORT ¿NEAR ANATOMIC¿ ALIGNMENT OF COMPONENTS. AT 4-MONTHS FU, ON (B)(6)2017 , PATIENT REPORTED ANTERIOR KNEE PAIN AROUND THE RATHER PROTRUDING TIBIAL TUBERCLE SCREW. KNEE ROM WAS REPORTED AS AN ADEQUATE 0° -120°. X-RAYS REPORTED MIGRATION OF THE TIBIAL TUBERCLE SCREW ON(B)(6)2017 . WITH LOCAL PERSISTENT PAIN AROUND THE TIBIAL TUBERCLE SCREW, IT WAS DECIDED TO REMOVE THIS SCREW AND AS SUCH WAS PERFORMED ON (B)(6)2017 . BACTERIAL CULTURES OF THE WOUND AROUND THE SCREW DID RESULT IN CULTURE OF METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). ANAEROBIC CULTURES WERE NEGATIVE. EARLY FU CONFIRMED ADEQUATE WOUND HEALING WITH PAIN RELIEF ALTHOUGH PAIN DID SHIFT NOW MORE TO BOTH HIPS. X-RAYS OF THE HIPS DID REVEAL HOWEVER ONLY MINIMAL HIP OA. X-RAYS OF THE RIGHT KNEE DID NOT SHOW ANY CHANGE IN COMPONENT POSITION. PHYSICAL THERAPY AND PAIN MEDICATION WERE REQUIRED TO ADDRESS THE COMPLAINTS. IT SHOULD BE NOTED THAT THE SCREW WITH SPIKE WASHER INVOLVED DURING THE REMOVAL PROCEDURE IN AUG 2017 WHERE NOT STRYKER DEVICES AS MANUFACTURED BY SYNTHES BUT STILL MAY ADD TO THE COMPLEXITY OF THE CASE AND THE POTENTIAL FOR LEGAL OR LITIGATION CONSEQUENCES. INFECTION IS A KNOWN POSSIBLE ADVERSE OUTCOME OF SURGERY, AS NOTED IN THE INSTRUCTIONS FOR USE. ALL STRYKER PRODUCTS SOLD AS STERILE ARE VALIDATED TO A MINIMUM STERILITY ASSURANCE LEVEL (SAL) OF 10^-6 IN ACCORDANCE TO APPLICABLE ISO STANDARDS. WHEN THE STERILE BARRIER OF ANY DEVICE IS OPENED, THE STERILITY OF THAT DEVICE BECOMES A FUNCTION OF HANDLING AND SURGICAL TECHNIQUE AND IS BEYOND STRYKER¿S CONTROL. INFECTION DUE TO BACTERIAL CONTAMINATION, AS SUPPLIED FROM THE MANUFACTURER, IS AN EXTREMELY RARE EVENT.

    Description of Event or Problem · 0

    MEDICAL RECORDS PROVIDED FOR LEGAL PI HAVE INDICATED ADDITIONAL TREATMENTS/REVISIONS THE PATIENT UNDERWENT. THIS PI IS FOR A REVISION SURGERY THE PATIENT UNDERWENT ON (B)(6)2017 . IT IS NOTED THAT THE REVISION SURGERY WAS OF COMPETITOR DEVICES, HOWEVER, THE EXISTENCE OF INFECTION OF THE WOUND AROUND THE SCREW (MRSA) IS REPORTED. EXCERPT FROM MEDICAL REVIEW: "WITH LOCAL PERSISTENT PAIN AROUND THE TIBIAL TUBERCLE SCREW, IT WAS DECIDED TO REMOVE THIS SCREW AND AS SUCH WAS PERFORMED ON (B)(6)2017 . BACTERIAL CULTURES OF THE WOUND AROUND THE SCREW DID RESULT IN CULTURE OF METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA)."

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: TRI TS BASEPLATE SIZE 2; CAT# 5521-B-200; LOT# UNKNOWN, TRI CEMENTED STEM 12MMX100MM; CAT# 5560-S-212; LOT# UNKNOWN, TRIATHLON SYM CONE AUG SZ B; CAT# 5549-A-120; LOT# UNKNOWN, SIMPLEX P - US TOBRA FD 10-PK; CAT# 61979010; LOT# MJX093. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    MEDICAL RECORDS PROVIDED FOR LEGAL PI HAVE INDICATED ADDITIONAL TREATMENTS/REVISIONS THE PATIENT UNDERWENT. THIS PI IS FOR A REVISION SURGERY THE PATIENT UNDERWENT ON (B)(6) 2017. IT IS NOTED THAT THE REVISION SURGERY WAS OF COMPETITOR DEVICES, HOWEVER, THE EXISTENCE OF INFECTION OF THE WOUND AROUND THE SCREW (MRSA) IS REPORTED. EXCERPT FROM MEDICAL REVIEW: "WITH LOCAL PERSISTENT PAIN AROUND THE TIBIAL TUBERCLE SCREW, IT WAS DECIDED TO REMOVE THIS SCREW AND AS SUCH WAS PERFORMED ON (B)(6) 2017. BACTERIAL CULTURES OF THE WOUND AROUND THE SCREW DID RESULT IN CULTURE OF METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124671 NO 2. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 07613327027068

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R