BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT X3 ELEVATED RIM 36MM ID

    MDR report key: 7534834 · Received May 22, 2018

    Report

    Report Number
    0002249697-2018-01527
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    May 1, 2013
    Report Date
    June 27, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING DISLOCATION (CLOSED REDUCTION 2) INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS CONFIRMED BY MEDICAL REVIEW METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: VISUAL, DIMENSIONAL, FUNCTIONAL INSPECTION, AND MATERIAL ANALYSIS WERE NOT PERFORMED AS THE ITEM WAS NOT RETURNED. -CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: ¿THERE IS NO EXAMINATION OF THE EXPLANTED COMPONENTS FROM EITHER REVISION AVAILABLE FOR REVIEW.¿ BASED UPON THE INFORMATION AVAILABLE FOR REVIEW, NO DETERMINATION CAN BE MADE FOR THE APPARENT FAILURE OF BIOLOGIC FIXATION WITHOUT MIGRATION OF THE PRIMARY ACETABULAR COMPONENT AS DESCRIBED IN THE REVISION OPERATIVE REPORT. PERSISTENT RADIOLUCENCIES IN ALL THREE ZONES OF THE ACETABULUM, THE DECISION NOT TO AUGMENT THE ACETABULAR FIXATION WITH SCREWS, AND THE HISTORY OF PREVIOUS TOBACCO USE, ALONG WITH POSSIBLE COMPONENT UNDER SIZING MAY HAVE BEEN CONTRIBUTORY. THE REVISION ACETABULUM WAS LARGER AND AUGMENTED WITH SCREWS. DISLOCATIONS AFTER REVISION SURGERY ARE MORE COMMON THAN AFTER PRIMARY SURGERY AND WITH A SMALLER COLLARED HEAD ARTICULATING WITH AN ELEVATED RIM INSERT, THE POSSIBILITY OF IMPINGEMENT INCREASES. THERE IS NO EVIDENCE THIS CLINICAL HISTORY WAS RELATED TO FACTORS OF COMPONENT DESIGN, MANUFACTURING OR MATERIALS.¿ -PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE REPORTED EVENT OF DISLOCATION, CLOSED REDUCTION 2 WAS CONFIRMED BY THE CLINICIAN¿S REVIEW. BASED ON THE CLINICIAN¿S REVIEW IT WAS NOTED, ¿THERE IS NO EXAMINATION OF THE EXPLANTED COMPONENTS FROM EITHER REVISION AVAILABLE FOR REVIEW. DISLOCATIONS AFTER REVISION SURGERY ARE MORE COMMON THAN AFTER PRIMARY SURGERY AND WITH A SMALLER COLLARED HEAD ARTICULATING WITH AN ELEVATED RIM INSERT, THE POSSIBILITY OF IMPINGEMENT INCREASES. THERE IS NO EVIDENCE THIS CLINICAL HISTORY WAS RELATED TO FACTORS OF COMPONENT DESIGN, MANUFACTURING OR MATERIALS.¿

    Description of Event or Problem · 0

    IT WAS REPORTED, NOTICE RECEIVED FROM PATIENT'S ATTORNEY ALLEGES THAT PATIENT HAD A STRYKER HIP PROSTHESIS WHICH WAS SUBJECT TO STRYKER'S RECALL. IT IS ALLEGED THAT THE PATIENT WOUND UP HAVING MANY OF THE SIGNS AND SYMPTOMS STRYKER SAID THE DEFECTIVE HIP WOULD CAUSE IN ITS RECALL NOTICE AND IN CONSULTATION WITH HIS ORTHOPAEDIC SURGEON HAS HAD A NUMBER OF PROCEDURES TO ADDRESS THE SIGNS AND SYMPTOMS HE WAS DISPLAYING, ULTIMATELY RESULTING IN THE PROSTHESIS BEING REMOVED. UPDATED PER MEDICAL REVIEW: ON (B)(6)2013 HE SUSTAINED A SECOND DISLOCATION, TREATED WITH CLOSED REDUCTION. THIS PI IS FOR THE SECOND DISLOCATION TREATED WITH CLOSED REDUCTION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. REVIEW OF THE PRODUCT HISTORY RECORDS INDICATES PRODUCTS WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED.

    Description of Event or Problem · 1

    IT WAS REPORTED, NOTICE RECEIVED FROM PATIENT'S ATTORNEY ALLEGES THAT PATIENT HAD A STRYKER HIP PROSTHESIS WHICH WAS SUBJECT TO STRYKER'S RECALL. IT IS ALLEGED THAT THE PATIENT WOUND UP HAVING MANY OF THE SIGNS AND SYMPTOMS STRYKER SAID THE DEFECTIVE HIP WOULD CAUSE IN ITS RECALL NOTICE AND IN CONSULTATION WITH HIS ORTHOPAEDIC SURGEON HAS HAD A NUMBER OF PROCEDURES TO ADDRESS THE SIGNS AND SYMPTOMS HE WAS DISPLAYING, ULTIMATELY RESULTING IN THE PROSTHESIS BEING REMOVED. UPDATED PER MEDICAL REVIEW: ON (B)(6) 2013 HE SUSTAINED A SECOND DISLOCATION, TREATED WITH CLOSED REDUCTION. THIS PI IS FOR THE SECOND DISLOCATION TREATED WITH CLOSED REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375061 TRIDENT X3 ELEVATED RIM 36MM ID PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH MLA4K9

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R