BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCOLADE (127 DEG) SIZE 4.5

    MDR report key: 6404617 · Received March 14, 2017

    Report

    Report Number
    0002249697-2017-00907
    Event Type
    Death
    Date Received
    March 14, 2017
    Date of Event
    November 8, 2016
    Report Date
    March 19, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PATIENT FACTORS INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: ¿ON (B)(6) 2007 A CONSULTATION NOTED A LEFT HIP SCREW PLACEMENT IN CHILDHOOD, CORONARY ARTERY DISEASE WITH CORONARY BYPASS IN HIS HISTORY, AND X-RAYS NOTED A LEFT HIP END-STAGE OSTEOARTHRITIS. [¿] ON (B)(6) 2009 A LEFT TOTAL HIP ARTHROPLASTY AND REMOVAL OF HARDWARE WAS PERFORMED FOR A DIAGNOSIS OF SEVERE DEGENERATIVE JOINT DISEASE OF THE LEFT HIP WITH RETAINED HARDWARE. [¿] ON (B)(6) 2016 THE PATIENT WAS ADMITTED WITH A DIAGNOSIS OF BACTERIAL PNEUMONIA AND BACTEREMIA. HE UNDERWENT INTENSIVE MEDICAL TREATMENT FOR MULTIPLE MEDICAL CONDITIONS INCLUDING "PRE-RENAL FAILURE, SHORTNESS OF BREATH, DYSMORPHIC LIVER, BILE DUCT FIBROSIS, PRIMARY SCLEROSING CHOLANGITIS, CONCERN FOR GI MALIGNANCY, CHRONIC ATRIAL FIBRILLATION ON WARFARIN, LASIX AND DIGITALIS TREATMENT FOR CARDIAC CONDITION" WHILE IN THE HOSPITAL, AND ON (B)(6) 2016 DIED. [¿] NO DOCUMENTED FOLLOW-UP BETWEEN (B)(6) OF 2009 AND (B)(6) OF 2016, NO X-RAYS OF THE TOTAL HIP ARTHROPLASTY, AND NO CONFIRMATION OF SYMPTOMS RELATED TO HIS TOTAL HIP ARE AVAILABLE FOR REVIEW. BASED UPON THE INFORMATION AVAILABLE FOR REVIEW THERE IS NO EVIDENCE THAT THE PATIENT WHO EXPIRED FROM CARDIAC DISEASE NINE YEARS STATUS-POST LEFT TOTAL HIP ARTHROPLASTY WAS ADVERSELY IMPACTED BY HIS LEFT HIP SURGERY NOR IS THERE ANY EVIDENCE THAT HE UNDERWENT A HIP REVISION." DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: NO OTHER EVENTS WERE REPORTED FOR THE LOT INDICATED. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE PATIENT PASSED AWAY DUE TO CARDIAC DISEASE. THE MEDICAL REVIEW CONCLUDED, ¿BASED UPON THE INFORMATION AVAILABLE FOR REVIEW THERE IS NO EVIDENCE THAT THE PATIENT WHO EXPIRED FROM CARDIAC DISEASE NINE YEARS STATUS-POST LEFT TOTAL HIP ARTHROPLASTY WAS ADVERSELY IMPACTED BY HIS LEFT HIP SURGERY NOR IS THERE ANY EVIDENCE THAT HE UNDERWENT A HIP REVISION.¿ NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT'S WIFE RECEIVED A RECALL LETTER. THE WIFE STATED THE PATIENT EXPIRED ON (B)(6) 2016 CAUSE OF DEATH WAS HEART FAILURE. SHE SAID HE WAS IN A LOT OF PAIN FOUR TO FIVE MONTHS PRIOR TO HIS PASSING; HE USED A WALKER AND CANE. LEFT HIP.

    Description of Event or Problem · 1

    PATIENT'S WIFE RECEIVED A RECALL LETTER. THE WIFE STATED THE PATIENT EXPIRED ON (B)(6) 2016 CAUSE OF DEATH WAS HEART FAILURE. SHE SAID HE WAS IN A LOT OF PAIN FOUR TO FIVE MONTHS PRIOR TO HIS PASSING; HE USED A WALKER AND CANE. LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186108 ACCOLADE (127 DEG) SIZE 4.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 22698404

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| O