BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 36MM/-5

    MDR report key: 8449071 · Received March 25, 2019

    Report

    Report Number
    0002249697-2019-01424
    Event Type
    Injury
    Date Received
    March 25, 2019
    Date of Event
    February 15, 2019
    Report Date
    July 11, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K173499
    Removal / Correction Number
    2249697-05/07/2018-003R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IMPLANT AND EXPLANT DATE AN EVENT REGARDING HEAD STEM TRUNNION WEAR (CONE WEAR) INVOLVING A METAL HEAD AND AN ACCOLADE STEM (PI 2021440) WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS -PRODUCT EVALUATION AND RESULTS: THE REPORTED DEVICE WAS NOT RETURNED HOWEVER PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPHS NOTE THE FOLLOWING: THE BASE OF THE HEAD IS SHOWN. DUE TO THE ANGLE AND LIGHTING OF THE PHOTO, IT IS NOT POSSIBLE TO EXAMINE THE INNER TAPER OF THE DEVICE. THERE IS NOTHING ELSE OF NOTE SHOWN. -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL INFORMATION BY A CLINICAL CONSULTANT INDICATED: ON (B)(6)2005 HE UNDERWENT A RIGHT NON-CEMENTED TOTAL HIP ARTHROPLASTY FOR A DIAGNOSIS OF COXARTHROSIS RIGHT HIP. A TRANSLATED OPERATIVE REPORT NOTES A MINIMALLY INVASIVE ANTERIOR APPROACH, AND THAT THE ACETABULUM WAS REAMED TO 56 MILLIMETERS FOR A 56 TRIDENT CUP. A 36MM INSERT, A #4 ACCOLADE STEM, AND A 36 METAL HEAD WERE ALSO UTILIZED, AND UNCOMPLICATED SURGERY WAS DESCRIBED. A POST- OPERATIVE X-RAY WAS NOTED TO SHOW ¿CORRECT IMPLANT POSITION¿. ON (B)(6)2019 A ¿STEM REVISION HIP JOINT ¿ RIGHT¿ WAS PERFORMED FOR A DIAGNOSIS OF ¿TAPER FRACTURE INVOLVING SEVERE METALOSIS ¿ TOTAL HIP REPLACEMENT RIGHT¿. A TRANSLATED OPERATIVE REPORT DESCRIBES GENERAL ANESTHESIA AND A POSTEROLATERAL APPROACH. THE OPERATIVE REPORT NOTES, ¿¿ BLACK-DISCOLORED AND BLOATED PIRIFORMIS MUSCLE ¿ CAPSULE HAS BEEN MASSIVELY DESTROYED BY METALOSIS ¿ CUP IS STABLE AND CAN REMAIN IN SITU ¿ INSERT, AS WELL AS THE HEAD AND THE DESTROYED TAPER ARE REMOVED ¿ STEM IS FIRMLY SEATED ¿ STEP BY STEP CIRCULATORY CHISELING ¿ STEM CAN BE KNOCKED OUT WITH VISE GRIP ¿ REAMING ¿ UNDER RADIOLOGIC GUIDANCE ¿ FOR STEM ¿ CERAMIC HEAD ¿ NEW LINER ¿¿. UNCOMPLICATED SURGERY WAS DESCRIBED. X-RAY PRINTOUT DATED (B)(6)2019 OFF OF THE FILM IS AN AP OF THE PELVIS DEMONSTRATING BILATERAL UNCEMENTED TOTAL HIP ARTHROPLASTIES. THE RIGHT HAS NO SCREWS IN THE ACETABULUM, THE HEAD IS IN THE ACETABULUM, AND THE STEM AND SHELL ARE WELL-FIXED AND PROPERLY ALIGNED. A DISPLACED TRANSVERSE FRACTURE AT THE BASE OF THE TRUNNION IS NOTED. THE LEFT TOTAL HIP ARTHROPLASTY HAS TWO SCREWS IN THE ACETABULUM. IT IS REDUCED IN NOMINAL POSITION, HOWEVER THE DISTAL LONG STEM IS NOT VISUALIZED. A COLOR PHOTOGRAPH OF AN INCISIONAL AREA, UNDATED AND UNLABELED, DEMONSTRATES A DEEP SUBCUTANEOUS FAT LAYER AND THE DEPTH OF THE INCISION IS NOTED TO BE STAINED WITH DARK MATERIAL. NO PATIENT DEMOGRAPHICS, NO CLINICAL OR PAST MEDICAL HISTORY, NO SERIAL X-RAYS, AND NO SURGICAL PATHOLOGY REPORT OR EXAMINATION OF EXPLANTED COMPONENTS ARE AVAILABLE. AFTER FOURTEEN YEARS IN SITU, A FATIGUE FRACTURE MAY HAVE OCCURRED AT THE PROSTHETIC FEMORAL NECK THAT MAY HAVE BEEN INITIATED BY A SCRATCH OR DEFECT IN THE LATERAL TENSILE SIDE OF THE FRACTURE SITE. SINCE THE DATE OF THE X-RAY IS FIVE DAYS PRIOR TO REVISION SURGERY, IT IS REASONABLE TO ASSUME AN EXTENDED PRE-REVISION PERIOD OF ABRASION OF THE FRACTURE AND THE STEM AGAINST THE METAL HEAD AND/OR THE ACETABULAR RIM RESULTED IN THE METALOSIS DESCRIBED. BASED UPON THE INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THIS LATE TERM CLINICAL EVENT. EXAMINATION OF THE EXPLANTED STEM AND ITS FRACTURE SURFACES WOULD BE REQUIRED TO DETERMINE POSSIBLE CAUSATION. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED. -PRODUCT HISTORY REVIEW: A REVIEW OF THE DEVICE MANUFACTURING RECORDS INDICATE THAT ALL DEVICES ACCEPTED INTO FINAL STOCK WERE FREE FROM DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE SUBJECT DEVICE HAS BEEN IDENTIFIED TO BE WITHIN SCOPE OF NC AND CAPA. LOT SPECIFIC VOLUNTARY RECALL WAS INITIATED FOR THE LFIT V40 COCR HEADS WITHIN SCOPE OFNC AND CAPA. THE INVESTIGATION REVEALED THAT ONLY SPECIFIC CATALOG NUMBERS AND SPECIFIC LOTS ARE IMPACTED BY THE REGULATORY ACTION AND THAT THE AFFECTED LOTS WERE MANUFACTURED ON OR BEFORE (B)(6)2011. THE ROOT CAUSE ANALYSES IDENTIFIED A PROCESS RELATED ANOMALY AS TO THE AFFECTED SIZES AND LOTS. THE AFFECTED PRODUCT HAS ALL BEEN IMPLANTED AND/OR EXPIRED. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 0

    THE PATIENT RECEIVED A CEMENTLESS HIP ENDOPROSTHESIS ON THE LEFT IN 2005. THE COMBINATION OF THE USED ACCOLADE SHAFT AND THE CORRESPONDING 36 MM METAL HEAD IN THE FOLLOWING YEARS AN INCREASED COMPLICATION RATE DUE TO CONE WEAR. AS EARLY AS 2014, THE PATIENT WAS SUSPECTED OF HAVING HAD A CONE WEAR, WHICH IS WHY HE WAS ADVISED TO CHANGE THE PROSTHESIS. THIS WAS NOT FOLLOWED BY THE PATIENT. ON (B)(6)2019 THE PATIENT KINKS AFTER 2-3 STEPS IN HIS OWN APARTMENT WITH HIS LEG AWAY. AT THE PRESENTATION IN THE EMERGENCY ROOM OF THE CLINIC, A FRACTURE OF THE CONE OF THE HIP ENDOPROSTHESIS WAS REVEALED. FOR THIS REASON, A NEW OPERATION OF THE HIP HAD TO BE DONE WITH A SHAFT CHANGE. INTRAOPERATIVELY, A MODERATE METALLOSIS WAS FOUND IN ABOUT 2/3 ABRADED CONE WHICH WAS LAST BROKEN UNDER LOAD.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A CEMENTLESS HIP ENDOPROSTHESIS ON THE LEFT IN 2005. THE COMBINATION OF THE USED ACCOLADE SHAFT AND THE CORRESPONDING 36 MM METAL HEAD IN THE FOLLOWING YEARS AN INCREASED COMPLICATION RATE DUE TO CONE WEAR. AS EARLY AS 2014, THE PATIENT WAS SUSPECTED OF HAVING HAD A CONE WEAR, WHICH IS WHY HE WAS ADVISED TO CHANGE THE PROSTHESIS. THIS WAS NOT FOLLOWED BY THE PATIENT. ON (B)(6) 2019 THE PATIENT KINKS AFTER 2-3 STEPS IN HIS OWN APARTMENT WITH HIS LEG AWAY. AT THE PRESENTATION IN THE EMERGENCY ROOM OF THE CLINIC, A FRACTURE OF THE CONE OF THE HIP ENDOPROSTHESIS WAS REVEALED. FOR THIS REASON, A NEW OPERATION OF THE HIP HAD TO BE DONE WITH A SHAFT CHANGE. INTRAOPERATIVELY, A MODERATE METALLOSIS WAS FOUND IN ABOUT 2/3 ABRADED CONE WHICH WAS LAST BROKEN UNDER LOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240690 V40 COCR LFIT HEAD 36MM/-5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH 19843901

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R