BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 36MM

    MDR report key: 8709613 · Received June 18, 2019

    Report

    Report Number
    0002249697-2019-02273
    Event Type
    Injury
    Date Received
    June 18, 2019
    Date of Event
    December 9, 2018
    Report Date
    June 27, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327025309
    PMA / PMN Number
    K062419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING DISLOCATION INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS CONFIRMED BY THE MEDICAL REVIEW. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND/OR X-RAYS BY A CLINICAL CONSULTANT INDICATED: "ON (B)(6) 2018 SHE UNDERWENT A PRIMARY RIGHT TOTAL HIP ARTHROPLASTY FOR WHICH NO OPERATIVE REPORT IS AVAILABLE. ON (B)(6) 2018 SHE UNDERWENT A REVISION RIGHT TOTAL HIP ARTHROPLASTY AND AN OPEN REDUCTION/INTERNAL FIXATION OF A PERIPROSTHETIC FRACTURE OF THE RIGHT FEMUR. NO OPERATIVE REPORT IS AVAILABLE FOR THIS. IMPLANT LABELS INDICATE A DALL-MILES MEDIUM 200ML TROCHANTERIC GRIP PLATE WITH TWO CABLES, ALONG WITH SIX ADDITIONAL DALL-MILES BEADED CABLE SETS AND SLEEVES, A 155/17 RESTORATION MODULAR HIP STEM, A 19/0 V-40 RESTORATION PROXIMAL BODY, AND A 36/MINUS-5 V-40 BIOLOX HEAD WERE UTILIZED... AN X-RAY PRINTOUT DATED (B)(6) 2018 IS AN AP OF THE RIGHT HIP DEMONSTRATING A COMMINUTED FRACTURE OF THE PROXIMAL FEMUR WITH A DISLOCATED UNCEMENTED TOTAL HIP ARTHROPLASTY WITH STEM SUBSIDENCE AND TWO SCREWS NOTED IN THE ACETABULUM. AN X-RAY DATED (B)(6) 2018 IS AN AP OF THE PELVIS, PORTABLE, DEMONSTRATING A RIGHT UNCEMENTED TOTAL HIP ARTHROPLASTY WITH THE SAME ACETABULAR COMPONENT, BUT A LONG-STEM MODULAR FEMORAL COMPONENT AND A LATERAL TROCHANTERIC GRIP PLATE FIXED WITH EIGHT CERCLAGE CABLES. THE FRACTURE IS ANATOMICALLY REDUCED, THE HIP IS REDUCED, AND THE COMPONENTS APPEAR IN NOMINAL POSITION...NO CLINICAL OR PAST MEDICAL HISTORY, NO OPERATIVE REPORTS AND NO EXAMINATION OF EXPLANTED COMPONENTS ARE AVAILABLE. THERE IS NO EVIDENCE THIS TRAUMATIC PERIPROSTHETIC FRACTURE WAS RELATED TO FACTORS OF FAULTY IMPLANT DESIGN, MANUFACTURING OR MATERIALS. IN RETROSPECT, A PRIMARY CEMENTED FEMORAL COMPONENT MAY HAVE AVOIDED THIS TRAUMATIC EVENT." DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSION: IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. A REVIEW OF THE PROVIDED MEDICAL RECORDS AND/OR X-RAYS BY A CLINICAL CONSULTANT INDICATED THAT AN X-RAY PRINTOUT DATED DECEMBER 8, 2018 IS AN AP OF THE RIGHT HIP DEMONSTRATING A COMMINUTED FRACTURE OF THE PROXIMAL FEMUR WITH A DISLOCATED UNCEMENTED TOTAL HIP ARTHROPLASTY WITH STEM SUBSIDENCE AND TWO SCREWS NOTED IN THE ACETABULUM. NO CLINICAL OR PAST MEDICAL HISTORY, NO OPERATIVE REPORTS AND NO EXAMINATION OF EXPLANTED COMPONENTS ARE AVAILABLE. THERE IS NO EVIDENCE THIS TRAUMATIC PERIPROSTHETIC FRACTURE WAS RELATED TO FACTORS OF FAULTY IMPLANT DESIGN, MANUFACTURING OR MATERIALS. IN RETROSPECT, A PRIMARY CEMENTED FEMORAL COMPONENT MAY HAVE AVOIDED THIS TRAUMATIC EVENT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. 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 · 0

    PATIENT HAD A PRIMARY TOTAL HIP ON (B)(6) 2018. SHE FELL IN REHAB AND FRACTURED HER FEMUR. SHE WAS TAKEN TO THE OR AND REVISED TO A CONE CONICAL WITH A DALL MILES TROCHANTERIC PLATE AND CABLES. OPERATION WAS COMPLETED SUCCESSFULLY. AS PER MEDICAL REVIEW: "...COMMINUTED FRACTURE OF THE PROXIMAL FEMUR WITH A DISLOCATED UNCEMENTED TOTAL HIP ARTHROPLASTY WITH STEM SUBSIDENCE."

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS CONFIRMED BY THE MEDICAL REVIEW. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND/OR X-RAYS BY A CLINICAL CONSULTANT INDICATED: "ON (B)(6) 2018 SHE UNDERWENT A PRIMARY RIGHT TOTAL HIP ARTHROPLASTY FOR WHICH NO OPERATIVE REPORT IS AVAILABLE. ON (B)(6) 2018 SHE UNDERWENT A REVISION RIGHT TOTAL HIP ARTHROPLASTY AND AN OPEN REDUCTION/INTERNAL FIXATION OF A PERIPROSTHETIC FRACTURE OF THE RIGHT FEMUR. NO OPERATIVE REPORT IS AVAILABLE FOR THIS. IMPLANT LABELS INDICATE A DALL-MILES MEDIUM 200ML TROCHANTERIC GRIP PLATE WITH TWO CABLES, ALONG WITH SIX ADDITIONAL DALL-MILES BEADED CABLE SETS AND SLEEVES, A 155/17 RESTORATION MODULAR HIP STEM, A 19/0 V-40 RESTORATION PROXIMAL BODY, AND A 36/MINUS-5 V-40 BIOLOX HEAD WERE UTILIZED. AN X-RAY PRINTOUT DATED (B)(6) 2018 IS AN AP OF THE RIGHT HIP DEMONSTRATING A COMMINUTED FRACTURE OF THE PROXIMAL FEMUR WITH A DISLOCATED UNCEMENTED TOTAL HIP ARTHROPLASTY WITH STEM SUBSIDENCE AND TWO SCREWS NOTED IN THE ACETABULUM. AN X-RAY DATED (B)(6) 2018 IS AN AP OF THE PELVIS, PORTABLE, DEMONSTRATING A RIGHT UNCEMENTED TOTAL HIP ARTHROPLASTY WITH THE SAME ACETABULAR COMPONENT, BUT A LONG-STEM MODULAR FEMORAL COMPONENT AND A LATERAL TROCHANTERIC GRIP PLATE FIXED WITH EIGHT CERCLAGE CABLES. THE FRACTURE IS ANATOMICALLY REDUCED, THE HIP IS REDUCED, AND THE COMPONENTS APPEAR IN NOMINAL POSITION...NO CLINICAL OR PAST MEDICAL HISTORY, NO OPERATIVE REPORTS AND NO EXAMINATION OF EXPLANTED COMPONENTS ARE AVAILABLE. THERE IS NO EVIDENCE THIS TRAUMATIC PERIPROSTHETIC FRACTURE WAS RELATED TO FACTORS OF FAULTY IMPLANT DESIGN, MANUFACTURING OR MATERIALS. IN RETROSPECT, A PRIMARY CEMENTED FEMORAL COMPONENT MAY HAVE AVOIDED THIS TRAUMATIC EVENT." -DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSION: IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. 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

    PATIENT HAD A PRIMARY TOTAL HIP (B)(6) 2018. SHE FELL IN REHAB AND FRACTURED HER FEMUR. SHE WAS TAKEN TO THE OR AND REVISED TO A CONE CONICAL WITH A DALL MILES TROCHANTERIC PLATE AND CABLES. OPERATION WAS COMPLETED SUCCESSFULLY. AS PER MEDICAL REVIEW: "...COMMINUTED FRACTURE OF THE PROXIMAL FEMUR WITH A DISLOCATED UNCEMENTED TOTAL HIP ARTHROPLASTY WITH STEM SUBSIDENCE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501057 TRIDENT 0 DEG INSERT 36MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH MA6MR6 07613327025309

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R