BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5

    MDR report key: 7616941 · Received June 19, 2018

    Report

    Report Number
    0002249697-2018-01892
    Event Type
    Injury
    Date Received
    June 19, 2018
    Date of Event
    December 19, 2017
    Report Date
    August 22, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    04546540510761
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING WEAR INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS CONFIRMED BY MEDICAL REVIEW. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS NO PRODUCTS WERE RETURNED. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND/OR X-RAYS BY A CLINICAL CONSULTANT INDICATED: " THE PATIENT UNDERWENT A PRIMARY PRESS-FIT THA ON (B)(6)2009. THIS HIP REPORTEDLY WENT ON TO FAILURE DUE TO WEAR BETWEEN THE FEMORAL HEAD AND THE TRUNNION AND REQUIRED REVISION. THE OPERATIVE FINDINGS REVISION SURGERY INCLUDED EXTENSIVE METALLOSIS FROM WORN TRUNNION. THE TRUNNION WAS FOUND TO BE GRINDING INTO THE BONE ANTEROSUPERIORLY ABOVE THE ACETABULUM. PROXIMAL 150MM DARK GREY FLUID WAS FOUND WITHIN THE JOINT. SIGNIFICANT MUSCLE NECROSIS OF THE OBTURATOR PIRIFORMIS AND GLUTEUS MINIMUS AND PARTIAL NECROSIS OF THE GLUTEUS MEDIUS WAS OBSERVED. THE COMPONENTS THEMSELVES WERE WELL FIXED HOWEVER NECROSIS OF THE BONE FROM THE SOCKET AND TROCHANTERIC PORTION OF THE FEMURE WAS IDENTIFIED. DURING THE REVISION PROCEDURE THOROUGH DEBRIDEMENT AND REMOVAL OF NECROTIC TISSUE WAS CARRIED OUT. THE ACCOLADE STEM WAS CAREFULLY REMOVED WITH FLEXIBLE OSTEOTOMES HOWEVER AN INADVERTENT FRACTURE TROCHANTER OCCURRED REQUIRING INTERNAL FIXATION WITH A DALL-MILES HOOK PLATE AND CABLES." 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 EVENT OF WEAR WAS CONFIRMED BASED ON THE PROVIDED MEDICAL REVIEW. REVIEW OF THE PROVIDED MEDICAL REVIEW REVEALED THAT "REVIEW OF THESE RECORDS CONFIRMS A REVISION THA FOR "WEAR BETWEEN THE HEAD AND TRUNNION" OCCURRED, ALONG WITH METALLOSIS AND SOFT TISSUE BONE DESTRUCTION HOWEVER, THE ROOT CAUSE CANNOT BE DETERMINED AS INSUFFICIENT INFORMATION WAS AVAILABLE" FURTHER INFORMATION SUCH AS IMPLANT RETRIEVAL WITH MATERIAL ANALYSIS, OPERATIVE REPORTS, DATED PRE AND POST OP X-RAYS/ IMAGING FROM THE INDEX AND REVISION SURGERIES, OUTPATIENT OFFICE/CLINIC NOTES AND SURGICAL PATHOLOGY REPORTS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED IN HIS LETTER TO STRYKER UK THAT HE UNDERWENT AN EMERGENCY REVISION OF HIS ACCOLADE / LFIT V40 RIGHT HIP REPLACEMENT AT THE (B)(6) HOSPITAL, HAYWARDS HEATH ON THE 19TH DECEMBER 2017 FOLLOWING EXTREME PAIN. SUPPLEMENTARY DOCUMENTATION PROVIDED BY THE PATIENT STATES THAT DURING THE REVISION, THE SURGEON, MR. P.S, FOUND EXTENSIVE METALLOSIS FROM A WORN TRUNNION THAT WAS GRINDING INTO THE BONE ANTEROSUPERIORLY TO THE SOCKET, A DARK GREY FLUID WITHIN THE JOINT, POCKETS OF PSEUDOTUMOUR, BONE NECROSIS AND SIGNIFICANT MUSCLE DAMAGE AROUND THE HIP. ENCLOSED NJR RECORDS SHOW THAT THE PRIMARY OPERATION WAS COMPLETED ON (B)(6) 2009 AT THE SUSSEX ORTHOPEDIC NHS TREATMENT CENTRE BY MR. T.M, AND THAT THE PATIENT WAS REVISED TO A RESTORATION MODULAR CONICAL DISTAL STEM, RESTORATION MODULAR CONE

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. 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. NOT RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED IN HIS LETTER TO STRYKER (B)(4) THAT HE UNDERWENT AN EMERGENCY REVISION OF HIS ACCOLADE / LFIT V40 RIGHT HIP REPLACEMENT AT THE (B)(6) HOSPITAL, (B)(6) ON THE (B)(6) 2017 FOLLOWING EXTREME PAIN. SUPPLEMENTARY DOCUMENTATION PROVIDED BY THE PATIENT STATES THAT DURING THE REVISION, THE SURGEON, MR.(B)(6) FOUND EXTENSIVE METALLOSIS FROM A WORN TRUNNION THAT WAS GRINDING INTO THE BONE ANTEROSUPERIORLY TO THE SOCKET, A DARK GREY FLUID WITHIN THE JOINT, POCKETS OF PSEUDOTUMOUR, BONE NECROSIS AND SIGNIFICANT MUSCLE DAMAGE AROUND THE HIP. ENCLOSED NJR RECORDS SHOW THAT THE PRIMARY OPERATION WAS COMPLETED ON (B)(6) 2009 AT THE (B)(6) CENTRE BY (B)(6) AND THAT THE PATIENT WAS REVISED TO A RESTORATION MODULAR CONICAL DISTAL STEM, RESTORATION MODULAR CONE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454976 ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 27702904 04546540510761

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| O| R