BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM CORAIL

    MDR report key: 15040494 · Received July 18, 2022

    Report

    Report Number
    1818910-2022-13183
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    February 3, 2021
    Report Date
    July 18, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: BELGAÏD V, VISTE A, FESSY MH. CEMENTLESS HYDROXYAPATITE-COATED STEM WITH DUAL MOBILITY AND POSTERIOR APPROACH IN OVER-80 YEAR-OLD PATIENTS WITH OSTEOARTHRITIS: RATES OF DISLOCATION AND PERIPROSTHETIC FRACTURE AT A MEAN 8 YEARS' FOLLOW-UP. ORTHOP TRAUMATOL SURG RES. 2022 APR;108(2):103196. DOI: 10.1016/J.OTSR.2021.103196. EPUB 2021 DEC 24. PMID: 34958972. OBJECTIVE AND METHODS: AUTHORS PERFORMED A RETROSPECTIVE ANALYSIS OF 120 PATIENTS TOTAL HIP ARTHROPLASTY (THA) WITH CORAIL STRAIGHT CEMENTLESS HYDROXYAPATITE-COATED FEMORAL STEMS PAIRED WITH COMPETITOR DUAL MOBILITY (DM) ACETABULAR CONSTRUCTS, IN PATIENTS AGED = 80 YEARS AT IMPLANTATION FOR OSTEOARTHRITIS OF THE HIP, ASSESSING PERIPROSTHETIC FRACTURE (PPF) RATE AND SURVIVAL FOR CEMENTLESS STRAIGHT STEMS PAIRED WITH DM CUPS, COMPLICATIONS¿HIP DISLOCATIONS IN PARTICULAR, AND CLINICAL SCORES. FOLLOW-UP WAS BETWEEN 5-10 YEARS (MEAN 8 YEARS). 48 PATIENTS HAD DIED AT THE TIME OF THE SURVEY-IMPLANT STATUS WAS CONFIRMED VIA FAMILIES OR PHYSICIANS FOR PURPOSES OF STUDY RESULTS. GIVEN THE AGE OF THE PATIENT POPULATION, THE AUTHORS OFFERED NO SUGGESTION OF ANY CORRELATION BETWEEN DEATHS AND THE IMPLANT DEVICES OR TOTAL HIP PROCEDURES. AUTHORS¿ HYPOTHESIS WAS THAT PPF AND DISLOCATION RATES ARE LOW IN THA WITH CEMENTLESS STRAIGHT STEM PAIRED WITH DM CUP IN PATIENTS AGED = 80 YEARS. RESULTS: AUTHORS FOUND THAT IN THE OVER 80 YEAR-OLD POPULATION, PRIMARY THA WITH STRAIGHT CEMENTLESS STEM AND 2ND GENERATION DUAL MOBILITY CUP WAS AN EFFECTIVE OPTION WITH LOW RISK OF PPF OR HIP DISLOCATION AFTER A MINIMUM 5-YEAR OF FOLLOW-UP. THERE WERE NO MAJOR PERIOPERATIVE COMPLICATIONS. THERE WERE 2 CASES OF INCOMPLETE INTRAOPERATIVE FRACTURE (CALCAR WEAKENING). IN BOTH CASES, METAL CERCLAGE AND A FEMORAL STEM WITH COLLAR WERE USED, WITH IMMEDIATE COMPLETE WEIGHT BEARING. THERE WERE 2 CASES OF PROSTHETIC INFECTION, AT 1 AND 4 MONTHS, RESPECTIVELY. ONE CASE REQUIRED I&D AND EXCHANGE OF THE INSERT AND THE FEMORAL HEAD; THE OTHER REQUIRED 2-STAGE REVISION OF ALL COMPONENTS. THERE WERE NO CASES OF SCIATIC PALSY, PSOAS IMPINGEMENT OR DEEP VENOUS THROMBOSIS. THERE WERE NO CASES OF ASEPTIC LOOSENING, OR STEM SUBSIDENCE >2MM. THERE WERE NO CASES OF DISLOCATION. THERE WERE 2 CASES OF POSTOPERATIVE PPF: ONE AT 2 MONTHS, SUSTAINED A BODY-HEIGHT FALL; STEM WAS REVISED TO LONG STEM AND INTERNAL PLATE WITH CERCLAGE FIXATION; AND THEN ONE AT 65 MONTHS, SUSTAINED A BODY-HEIGHT FALL; STEM WAS RETAINED, AND A LARGE INTERNAL PLATE AND CERCLAGE FIXATION WAS UTILIZED TO ADDRESS FRACTURE DISTAL TO THE STEM IMPLANT. THERE WAS ONE CASE OF DISTAL FEMUR FRACTURE, NOT INVOLVING THE HIP PROSTHESIS, TREATED WITH ORIF. COMPLICATIONS: 3: PERIPROSTHETIC FEMUR (1-POST-OP) OR CALCAR FRACTURES (2-INTRA-OP) TREATED WITH ORIF; 1: PERIPROSTHETIC FEMUR FRACTURES TREATED WITH FEMORAL STEM REVISION AND ORIF; 1: DISTAL FEMUR FRACTURE TREATED WITH ORIF; 1: INFECTION TREATED WITH WASHOUT I&D AND HEAD AND LINER EXCHANGE; 1: INFECTION TREATED WITH 2 STAGE REVISION OF ALL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212139 UNK HIP FEMORAL STEM CORAIL FEMORAL STEM LPH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention