BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 15041457 · Received July 18, 2022

    Report

    Report Number
    1818910-2022-13232
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    July 28, 2021
    Report Date
    July 18, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: BOYLE AB, ZHU M, FRAMPTON C, VANE A, POUTAWERA V. COMPARING UNCEMENTED, HYBRID AND CEMENTED PRIMARY TOTAL HIP ARTHROPLASTY IN YOUNG PATIENTS, A NEW ZEALAND JOINT REGISTRY STUDY. ARCH ORTHOP TRAUMA SURG. 2021 JUL 28. DOI: 10.1007/S00402-021-04085-7. EPUB AHEAD OF PRINT. PMID: 34319471. OBJECTIVE AND METHODS: THE AUTHORS ANALYZED THE MOST COMMONLY USED UNCEMENTED (CORAIL-PINNACLE), HYBRID (COMPETITOR), AND FULLY CEMENTED (COMPETITOR) IMPLANT COMBINATIONS IN THE NEW ZEALAND JOINT REGISTRY (NZJR) IN 27,738 PATIENTS AGED UNDER 40 AND BETWEEN 40 AND 55 YEARS FOR THAS RECORDED IN THE NZJR BETWEEN 1999 AND 2018. THE MANUFACTURERS OF THE ACETABULAR LINER AND FEMORAL HEADS USED IN THE DEPUY THA WERE NOT SPECIFIED BUT ASSUMED TO BE DEPUY PRODUCTS. THIS COMPLAINT WILL CAPTURE THE EVENTS ASSOCIATED WITH THE 103 DEPUY CORAIL/PINNACLE THA REVISIONS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: CORAIL STEM, PINNACLE CUP, UNK LINER, UNK FEMORAL HEAD ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH DEPUY DEVICES: THERE WERE 103 REVISIONS OF THE DEPUY THAS. THE AUTHORS SPECIFY NUMBERS OF EACH DEVICE REVISED, BUT DO NOT IDENTIFY WHICH PRODUCTS WERE REVISED IN EACH REVISION. TOTAL DEVICES REVISED: 48 STEMS, 27 CUPS, 57 HEADS, 73 LINERS. REASONS FOR REVISION: 4 CUP REVISIONS FOR LOOSENING, 25 STEM REVISIONS FOR LOOSENING, 17 REVISIONS FOR DISLOCATION, 21 REVISIONS FOR PAIN, 21 REVISIONS FOR DEEP INFECTION, 4 REVISIONS FOR PPF OF FEMUR, 32 REVISIONS FOR OTHER, UNSPECIFIED, REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2884736 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention