BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP ACETABULAR LINER POLY

    MDR report key: 20048338 · Received August 23, 2024

    Report

    Report Number
    1818910-2024-17889
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    May 29, 2023
    Report Date
    August 23, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CHEUNG A, CHAN PK, FU H, CHEUNG MH, CHAN VWK, LUK MH, CHIU KY. METAL-ON-CROSSLINKED POLYETHYLENE IN TOTAL HIP ARTHROPLASTY - AN EXCELLENT COMBINATION AT FIFTEEN TO TWENTY YEARS OF FOLLOW-UP. INT ORTHOP. 2023 OCT;47(10):2547-2552. DOI: 10.1007/S00264-023-05844-4. EPUB 2023 MAY 29. PMID: 37247019. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO FIRST DETERMINE THE LONG TERM CLINICAL AND RADIOLOGICAL RESULTS AND SECOND INVESTIGATE WHAT FACTORS AFFECT WEAR RATES USING A METAL-ON-CROSSLINKED PE BEARING ARTICULATION. BETWEEN DECEMBER 2001 AND JUNE 2006, A TOTAL OF 167 TOTAL HIP REPLACEMENTS WERE PERFORMED IN OUR INSTITUTION. 144 HIPS USED THE DURALOC (DEPUY, WARSAW, IN, USA) CEMENTLESS CUP. AFTER EXCLUDING OTHER TYPES OF BEARING COUPLING, 132 HIPS WERE LEFT USING THIS BRAND OF ACETABULAR CUP, MARATHON (DEPUY, WARSAW, IN, USA), A CROSSLINKED POLYETHYLENE LINER AND 28 MM METAL FEMORAL BALL. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNK HIP ACETABULAR CONSTRUCT DURALOC, UNKNOWN HIP ACETABULAR CUP DURALOC, AND THE UNK HIP ACETABULAR LINER POLY ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH: UNK HIP ACETABULAR CONSTRUCT DURALOC (QTY.(B)(4) -(N=3) INFECTION, TREATMENT: REVISION ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH: UNKNOWN HIP ACETABULAR CUP DURALOC (QTY. (B)(4) -(N=1) LOOSENING, TREATMENT: REVISION ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH: UNK HIP ACETABULAR LINER POLY (QTY (B)(4) -(N=1) DISLOCATION, TREATMENT: REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380710 UNK HIP ACETABULAR LINER POLY ACETABULAR LINER LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention