BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 15102343 · Received July 26, 2022

    Report

    Report Number
    1818910-2022-13987
    Event Type
    Injury
    Date Received
    July 26, 2022
    Date of Event
    March 24, 2021
    Report Date
    July 26, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. LITERATURE CITATION: MOU P, ZENG WN, CHEN Y, ZHOU Z. SYNCHRONOUS OR SEQUENTIAL CEMENTLESS BILATERAL TOTAL HIP ARTHROPLASTY FOR OSSEOUS ANKYLOSED HIPS WITH ANKYLOSING SPONDYLITIS. BMC MUSCULOSKELET DISORD. 2021 MAR 24;22(1):302. DOI: 10.1186/S12891-021-04142-7. PMID: 33761925; PMCID: PMC7988988. OBJECTIVE/METHODS/STUDY DATA: 23 PATIENTS (46 HIPS) WERE RETROSPECTIVELY ANALYZED AND DIVIDED INTO BILATERAL THA SYNCHRONOUSLY (GROUP A) AND SEQUENTIALLY (GROUP B). THE CLINICAL MEASUREMENT, RADIOLOGICAL ASSESSMENTS, AND COMPLICATIONS WERE COMPARED. INDEPENDENT SAMPLE T TEST WAS USED FOR DATA ANALYSIS. ONLY ONE SINGLE BRAND (DEPUY) OF THE CEMENTLESS CUP AND STEM IMPLANTS WERE USED FOR ALL PATIENTS. THE FRICTION INTERFACES USED INCLUDED CERAMIC-ON-CERAMIC (COC) OR CERAMIC-ON-POLYETHYLENE (COP), WHICH WERE DECIDED ACCORDING TO THE AGE, LEVEL OF ACTIVITY, AND PATIENTS¿ FINANCIAL SITUATION. THE ARTICLE DOES NOT IDENTIFY WHICH DEPUY PRODUCTS WERE UTILIZED. FIGURE 1 DEPICTS A MAN WITH BILATERAL THA WITH NO ADVERSE EVENTS NOTED BUT NO IDENTITY OF THE SPECIFIC DEPUY PRODUCTS UTILIZED. CAPTION REPORTS RADIOGRAPH AT 100 MONTH SHOWS NO ASEPTIC LOOSENING OR MIGRATION. FIGURE 2 DEPICTS A MAN WITH SINGLE AND THEN CONTRALATERAL THA'S WITH NO ADVERSE EVENTS AND NO IDENTITY OF THE SPECIFIC DEPUY PRODUCTS UTILIZED. CAPTION REPORTS 97 MONTH FOLLOW SHOWS GOOD FIXATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY UNKNOWN BLOOD TRANSFUSIONS ADMINISTERED. QTY 2 FEMORAL FRACTURE INTRAOPERATIVELY FIXED WITH SEVERAL DOUBLE-LOOP CERCLAGE WIRES - PATIENTS CONDUCTED FUNCTIONAL EXERCISE IN BED UNTIL FRACTURE HEALED. QTY 1 PATIENT EXPERIENCED HIP DISLOCATION AND DELAY UNION OF WOUND. QTY 6 HETEROTOPIC OSSIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340806 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention