BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP ACETABULAR CUP PINNACLE

    MDR report key: 22286417 · Received June 18, 2025

    Report

    Report Number
    1818910-2025-10043
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    March 17, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    J&J MEDTECH IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH J&J MEDTECH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, J&J MEDTECH OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, J&J MEDTECH, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION 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. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION, THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS REQUIRED AT THIS TIME. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SHERIDAN GA, LOWE LYH, HUGHES AJ, COURTNEY PM, SIDHU A, MACDONELL T, HOWARD LC, NEUFELD ME, GARBUZ DS, MASRI BA. THE SELECTIVE USE OF ACETABULAR SCREWS IN ROUTINE PRIMARY TOTAL HIP ARTHROPLASTY IS NONINFERIOR TO HABITUAL SCREW USE. J ARTHROPLASTY. 2025 MAR 17:S0883-5403(25)00246-3. DOI: 10.1016/J.ARTH.2025.03.034. EPUB AHEAD OF PRINT. PMID: 40107575. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE INTERNATIONAL MULTICENTER COHORT STUDY WAS TO ASSESS IF SELECTIVE SCREW INSERTION CAN ACHIEVE LOW RATES OF ACETABULAR COMPONENT LOOSENING AND WHETHER THIS APPROACH TO SCREW USAGE IS NONINFERIOR TO HABITUAL SCREW INSERTION. BETWEEN JANUARY 1, 2005 AND DECEMBER 31, 2022 (OVER 17-YEAR PERIOD), 4,708 ACETABULAR COMPONENTS FOR ALL PRIMARY THAS PERFORMED WERE ASSESSED AT A MEAN FOLLOW-UP OF 6.5 YEARS (RANGE, ONE TO 18.5) FOR THE WHOLE GROUP. THERE WERE 3,855 ACETABULAR COMPONENTS IN THE SELECTIVE NO-SCREW (SNS) GROUP, 734 IN THE SELECTIVE WITH-SCREW (SWS) GROUP, AND 118 COMPONENTS IN THE HABITUAL (H) GROUP. THERE WERE 48% MEN IN THE SELECTIVE SCREW GROUP AND 55% MEN IN THE H GROUP. THE MEAN AGE WAS 62 YEARS (RANGE, 14 TO 96) IN THE SELECTIVE GROUP AND 64 YEARS (RANGE, 36 TO 90) IN THE H GROUP. THE HABITUAL USER USED 90 TRIDENT ACETABULAR COMPONENTS (STRYKER, MAHWAH, NEW JERSEY), 27 G7 COMPONENTS (ZIMMER-BIOMET, WARSAW, INDIANA), AND ONE PINNACLE COMPONENT (DEPUY SYNTHES, WARSAW, INDIANA). FOR THE SELECTIVE USER, SCREWS WERE NOT ROUTINELY INSERTED UNLESS ADDITIONAL FIXATION WAS REQUIRED (E.G., SUBOPTIMAL STABILITY, POOR BONE QUALITY, AND POOR BONE COVERAGE). THE COMPONENT OF CHOICE FOR ALL SELECTIVE USERS WAS THE PINNACLE ACETABULAR COMPONENT (DEPUY SYNTHES). THE MEAN FOLLOW-UP WAS 6.9 YEARS (RANGE, 2.3 TO 15.1) FOR THE SWS GROUP, 6.5 YEARS (RANGE, 2.3 TO 14.3) FOR THE SNS GROUP, AND 2.75 YEARS (RANGE, ONE TO 5.5) FOR THE H GROUP. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES PINNACLE ACETABULAR COMPONENT OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: FEMORAL STEMS (UNKNOWN MANUFACTURER). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CUP PINNACLE (QTY 11): (N=9) ASEPTIC LOOSENING; UNDERWENT REVISION, (N=2) LINER DISSOCIATION; UNDERWENT REVISION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR LINERS (QTY 2): (N=2) LINER DISSOCIATION; UNDERWENT REVISION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CONSTRUCT PINNACLE (QTY 32): (N=13) INSTABILITY; UNDERWENT REVISION, (N=3) PERIPROSTHETIC FRACTURE; UNDERWENT REVISION, (N=2) PROSTHETIC JOINT INFECTION; UNDERWENT REVISION, (N=8) PSEUDOTUMOR; UNDERWENT REVISION, (N=6) OTHER/PAIN UNKNOWN ORIGIN; UNDERWENT REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911500 UNK HIP ACETABULAR CUP PINNACLE HIP ACETABULAR CUP JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention