BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE TMZF HIP STEM #3

    MDR report key: 6269631 · Received January 23, 2017

    Report

    Report Number
    0002249697-2017-00284
    Event Type
    Injury
    Date Received
    January 23, 2017
    Date of Event
    December 20, 2016
    Report Date
    April 3, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    04546540510556
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING AN ACCOLADE STEM WAS REPORTED. A REVIEW BY A CLINICAL CONSULTANT CONFIRMED A PERIPROSTHETIC FRACTURE AND SUBSIDENCE. METHOD AND RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: THE ACCOLADE STEM WAS RETURNED ASSEMBLED WITH THE CERAMIC HEAD. A CLINICIAN REVIEWED STEM EXPLANT IMAGES AND NOTED "MINIMAL ADHERENT BONE ON INGROWTH SURFACE OF STEM CONSISTENT WITH THE SHORT IMPLANTATION TIME." -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND/ X-RAY BY A CLINICAL CONSULTANT INDICATED THE STEM HAS SUBSIDED SOME 1-CM BELOW THE LEVEL OF THE CALCAR WITH THE FRACTURE ITSELF NOT VISIBLE DUE TO OVER PROJECTION OF METAL. THE STEM HAS AN ADEQUATE SIZE. BONE QUALITY OF THE FEMORAL DIAPHYSIS APPEARS ADEQUATE ALTHOUGH THE BONE IN THE GREATER TROCHANTERIC AREA IS RATHER THIN SUGGESTING LOCAL OSTEOPOROSIS. OF FURTHER RELEVANCE IS THE OBSERVED ¿SURFACE IRREGULARITY¿ ON THE INNER SIDE OF THE POLYBEARING AS REPORTED BY THE SURGEON AND ALSO SEEN ON THE RELEVANT EXPLANT PHOTOGRAPH. THE CAUSE OF THIS IS NOT DIRECTLY CLEAR AND REQUIRES A MORE EXTENSIVE MATERIALS ANALYSIS BY STRYKER¿S ENGINEERING GROUP. THE APPEARANCE IS CERTAINLY NOT ONE OF ¿REGULAR WEAR¿ BUT MORE ONE OF SURFACE IMPACT DAMAGE BY BLUNT TRAUMA. AS SUCH, NO EVIDENT PATHOLOGY OF THE RETRIEVED LINER WAS OBSERVED AND OBSERVED CHANGES ARE CONSISTENT WITH IN-VIVO SERVICE-RELATED DAMAGES INCLUDING EXPLANTATION DAMAGE AND THIRD-BODY WEAR DEBRIS. ALSO THE IMPACT OF THE PATIENT¿S TRAUMA WITH FALL MAY HAVE CONTRIBUTED TO SAME. THERE IS NO EVIDENCE AVAILABLE IN THE CURRENT CASE TO SUGGEST THAT DEVICE-RELATED ISSUES HAVE PLAYED A ROLE AS ALSO SUPPORTED BY THE MAR FINDINGS WHILE THE DISCUSSED ADVERSE MIX OF PATIENT- AND PROCEDURE-RELATED FACTORS SHOULD BE CONSIDERED MORE THAN ADEQUATE TO HAVE CAUSED THE PERIPROSTHETIC FRACTURE PROBLEM OF THIS PATIENT. THIS PI CASE IS NOT DEVICE-RELATED. -DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES.. -COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: A REVIEW BY A CLINICAL CONSULTANT CONCLUDED: AN ADVERSE MIX OF PATIENT-RELATED (OSTEOPOROSIS) AND PROCEDURE-RELATED FACTORS (SURGICAL PREPARATION IN OSTEOPOROTIC BONE) HAS CAUSED A PERI-PROSTHETIC FRACTURE REQUIRING REVISION SURGERY. EXPLANT MATERIALS ANALYSIS OF THE RETRIEVED POLY LINER CONFIRMS IN-VIVO SERVICE RELATED DAMAGES INCLUDING EXPLANTATION DAMAGE AND THIRD-BODY WEAR DEBRIS BUT NO EVIDENT PATHOLOGY. IF FURTHER INFORMATION BECOMES AVAILABLE THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    SURGEON REPORTED TO SCRUB NURSE THE FOLLOWING: PATIENT RECEIVED ON (B)(6) 2016 AN ACCOLADE/TRIDENT/ X3 36MM AND ALUMINA HEAD 36MM +0. AFTER 2 WEEKS ((B)(6) 2016) PATIENT ARRIVED AT EMERGENCY ROOM WITH PAIN IN GROIN AND HOSPITALIZED. CT SCAN IS MADE ON (B)(6) 2016 AND SHOWN FISSURE IN FEMUR. AGAIN SURGERY ON (B)(6) 2016, REMOVE ACCOLADE/ ALUMINA HEAD AND BECAUSE OF ABRASIVE WEAR OF X3 POLY INSERT, ALSO REMOVED POLY INSERT. SURGEON PLACED A LONG EXETER STEM AND A NEW INSERT.

    Description of Event or Problem · 1

    SURGEON REPORTED TO SCRUB NURSE THE FOLLOWING: PATIENT RECEIVED ON (B)(6) 2016 AN ACCOLADE/TRIDENT/ X3 36MM AND ALUMINA HEAD 36MM +0. AFTER 2 WEEKS ((B)(6) 2016) PATIENT ARRIVED AT EMERGENCY ROOM WITH PAIN IN GROIN AND HOSPITALIZED. CT SCAN IS MADE ON (B)(6) 2016 AND SHOWN FISSURE IN FEMUR. AGAIN SURGERY ON (B)(6) 2016, REMOVE ACCOLADE/ ALUMINA HEAD AND BECAUSE OF ABRASIVE WEAR OF X3 POLY INSERT, ALSO REMOVED POLY INSERT. SURGEON PLACED A LONG EXETER STEM AND A NEW INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54130 ACCOLADE TMZF HIP STEM #3 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 49134804 04546540510556

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R