BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANT LINER

    MDR report key: 9458810 · Received December 12, 2019

    Report

    Report Number
    0002249697-2019-04010
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    September 12, 2012
    Report Date
    December 12, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LEGAL REQUIREMENT (LETTER) FROM THE COURT - THE PATIENT (B)(6) HAS FILED A LEGAL COMPLAINT TO STRYKER AND AFTER HIS IMPLANTATION THE (B)(6) 2012 OF AN ABG-II LEFT HIP PROSTHESIS. ORIGINAL FILE UPLOADED AS WELL WITH ALL MEDICAL RECORDS (WITHOUT PATIENT NAME). MR (B)(6), VICTIM OF A FALL DOWN HIS STAIRS IN (B)(6) 2012 CAUSING OSTEONECROSIS OF THE LEFT FEMORAL HEAD RECEIVED SURGERY PERFORMED BY DR CONSISTING OF THE INSTALLATION OF A TOTAL LEFT HIP PROSTHESIS, AN ABG 2 NON-CEMENTED PROSTHESIS BY STRYKER, ON (B)(6) 2012. MAY 6, 2013, THE (B)(6) HAVE SPECIFIED THE RECOMMENDATIONS FOR FOLLOW-UP OF PATIENTS WITH THESE IMPLANTS, AND MORE SPECIFICALLY, THE MONITORING OF THE "COBALTEMIA WHOSE VALUE IN WHOLE BLOOD IS NORMALLY < 2UG/L" RECOMMENDING IN THIS CASE A "SURGICAL REVISION. AS OF (B)(6) 2014, MR (B)(6) WAS RUSHED TO THE HOSPITAL FOR CHEST PAIN AND RECEIVED: A CORONARY ANGIOGRAPHY, AND THE PLACEMENT OF AN ACTIVE STENT ON IVA 2. 1FT TO (B)(6) 2015, MR (B)(6) WAS AGAIN HOSPITALIZED AT THE HOSPITAL FOR "A RECURRENCE OF CHEST PAIN. FROM (B)(6) 2015, MR (B)(6) WAS HOSPITALIZED AT THE HOSPITAL, THIS TIME IN THE DEPARTMENT OF DIGESTIVE SURGERY AND DIGESTIVE ONCOLOGY FOR THE MANAGEMENT OF A "LEFT INGUINAL HERNIA CURE BY DIRECT APPROACH WITH PROSTHESIS PLACEMENT. MR. (B)(6) STATE OF HEALTH THEN NECESSITATED ON (B)(6) 2015: ANGIOPLASTY WITH BARE STENT IMPLANTATION (EXHIBIT 12) ON (B)(6) 2016: PLACEMENT OF AN ACTIVE STENT AND RE-STENOSIS OF THE AVERAGE RIGHT CORONARY TREATED WITH 2 ACTIVE STENTS (EXHIBIT 14). ON (B)(6) 2016: HOSPITALIZATION IN THE CARDIOLOGY DEPARTMENT FOLLOWING PERSISTENT CHEST PAIN AND SKIN ALLERGIES (EXHIBITS N°15 AND 16). ON (B)(6) 2017: ANGIOPLASTY WITH ACTIVE STENT PLACEMENT (PARTS 18 AND 19). CARDIAC ULTRASOUNDS FROM 2016 TO 2019 (EXHIBIT N°26). CORONARY ANGIOGRAPHY. SINCE THE INSTALLATION OF THE PROSTHETIC EQUIPMENT, MR (B)(6): HAD 3 HEART ATTACKS AND HAD AT LEAST 7 STENTS PLACED. HAS HAD MULTIPLE CORONARY ANGIOGRAMS STILL HAS CHEST PAIN. MR. (B)(6) ALSO PRESENTED MANY OTHER UNEXPLAINED PATHOLOGIES: SEVERAL DISLOCATIONS, WALKING PAIN IN HIS 2012 LEFT HIP REPLACEMENT WITH "MUSCULAR INSUFFICIENCY MARKED BY WALKING PAIN AND LIMPING... ", REQUIRING THE PRESCRIPTION BY HIS ATTENDING, PHYSICIAN OF MASSAGE AND REHABILITATION SESSIONS, ON (B)(6) 2019. (EXHIBIT 22), UNEXPLAINED RASHES AND ITCHING OF THE SKIN, (EXHIBITS 16 AND 38), AN AGGRAVATION OF OPTIC NEURITIS (EXHIBITS N°38), AN ANXIOUS DEPRESSIVE SYNDROME REQUIRING HIS HOSPITALIZATION IN (B)(6) 2018 IN FRONT OF SUICIDAL THOUGHTS AT THE INVOLVING SEROTONIN ANTIDEPRESSANT TREATMENT, THE ADAPTATION OF HIS ANXIOLYTIC TREATMENT AND REGULAR PSYCHIATRIC FOLLOW-UP, WHICH IS STILL ONGOING. IT IS JUSTIFIED THAT A CEMENTLESS STRYKER ABG II TOTAL HIP REPLACEMENT WAS IMPLANTED DURING THE SURGICAL OPERATION ON (B)(6) 2012, I. E. 1 MONTH AFTER THE MANUFACTURER'S RECALL OF THIS TYPE OF PRODUCT. ACCORDING TO AN ANALYSIS CARRIED OUT ON 12.08.2019, THE COBALT ASSAY IN PLASMA SHOWED A FURTHER INCREASE IN COBALTEMIA, NAMELY 305.5 UG/L FOR A NORMAL OF LESS THAN 0.8 UG/1L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253073 UNKNOWN IMPLANT LINER PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R