BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM CORAIL

    MDR report key: 19486434 · Received June 7, 2024

    Report

    Report Number
    1818910-2024-12431
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    March 17, 2023
    Report Date
    June 6, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PARK JW, KO YS, LEE YK, HA YC, KOO KH. TEN TO 13-YEAR RESULTS OF DELTA CERAMIC-ON-CERAMIC TOTAL HIP ARTHROPLASTY IN PATIENTS LESS THAN 30 YEARS OLD. J BONE JOINT SURG AM. 2023 MAY 17;105(10):789-796. DOI: 10.2106/JBJS.22.01291. EPUB 2023 MAR 22. PMID: 36947597. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT 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. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED, AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION, MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: THE DEVICE LOT NUMBER IS UNKNOWN. THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PARK JW, KO YS, LEE YK, HA YC, KOO KH. TEN TO 13-YEAR RESULTS OF DELTA CERAMIC-ON-CERAMIC TOTAL HIP ARTHROPLASTY IN PATIENTS LESS THAN 30 YEARS OLD. J BONE JOINT SURG AM. 2023 MAY 17;105(10):789-796. DOI: 10.2106/JBJS.22.01291. EPUB 2023 MAR 22. PMID: 36947597. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THE CURRENT STUDY WAS TO ASSESS CLINICAL AND RADIOGRAPHIC OUTCOMES, COMPLICATIONS (WITH A FOCUS ON CERAMIC-RELATED COMPLICATIONS, AND SURVIVORSHIP AT >10 YEARS AFTER THA USING THE DELTA COC BEARING IN 76 PATIENTS WHO WERE <30 YEARS OLD IMPLANTED BETWEEN MARCH 2008 AND JANUARY 2012 THIS STUDY IS THE SECOND REPORT FOR THE COHORT. THE AUTHORS UTILIZED IMPLANTS MANUFACTURED BY DEPUY AND COMPETITORS. THIS COMPLAINT WILL CAPTURE THE RESULTS ASSOCIATED WITH KNOWN DEPUY PRODUCTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN CORAIL STEM, UNKNOWN PINNACLE CUP, UNKNOWN CERAMIC FEMORAL HEAD, UNKNOWN CERAMIC ACETABULAR LINER. RADIOLOGICAL FINDINGS AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK CORAIL STEM (QTY 10) 9 STEMS WITH REPORTED RADIOLUCENT LINES- NO TREATMENT PROVIDED, AND NO INFORMATION ASSOCIATED WITH THIS MINOR INJURY. 1 STEM WITH FEMORAL OSTEOLYSIS- NO TREATMENT PROVIDED FOR THIS MINOR INJURY. RADIOLOGICAL FINDINGS AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK PINNACLE CUP (QTY 1) CASE #1: 33-YEAR-OLD FEMALE PATIENT WITH RADIOGRAPHICALLY IDENTIFIED ACETABULAR OSTEOLYSIS AROUND THE PINNACLE CUP. NO TREATMENT PROVIDED FOR THIS MINOR INJURY. RADIOLOGICAL FINDINGS AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK CORAIL STEM (QTY 1) CASE #2: A 24-YEAR-OLD MALE PATIENT WITH RADIOGRAPHICALLY IDENTIFIED RADIOLUCENT LINES AROUND THE CORAIL STEM. NO TREATMENT PROVIDED AND NO INFORMATION ASSOCIATED WITH THIS MINOR INJURY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK CORAIL STEM (QTY 1) CASE #3: 33-YEAR-OLD MALE PATIENT RECEIVED A FEMORAL STEM REVISION AND ORIF TO TREAT A FEMORAL FRACTURE AFTER A FALL. THE PINNACLE CUP AND CERAMIC LINER WERE RETAINED. THERE WAS NO INDICATION THE REVISED CERAMIC FEMORAL HEAD CONTRIBUTED TO THE FALL OR FEMORAL FRACTURE. THE PATIENT WAS REVISED WITH UNKNOWN PRODUCTS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK CERAMIC LINER (QTY 10) 10 REPORTS OF SQUEAKING. NO TREATMENT PROVIDED AND NO ADDITIONAL INFORMATION FOR THIS MINOR INJURY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK CERAMIC HEAD (QTY 10) 10 REPORTS OF SQUEAKING. NO TREATMENT PROVIDED AND NO ADDITIONAL INFORMATION FOR THIS MINOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436934 UNK HIP FEMORAL STEM CORAIL FEMORAL STEM LZO DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNK HIP ACETABULAR CUP PINNACLE| UNK HIP ACETABULAR LINER CERAMIC| UNK HIP FEMORAL HEAD CERAMIC