BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CONSTRUCT PINNACLE

    MDR report key: 22233425 · Received June 17, 2025

    Report

    Report Number
    1818910-2025-09867
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    April 5, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. H3, H6: 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. 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. 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: COCHONAT M, MESNARD G, KOUTSERIMPAS C, FAVROUL C, BATAILLER C, LUSTIG S. MINIMUM FIVE-YEAR OUTCOMES OF CEMENTED MONOBLOC DUAL-MOBILITY CUPS IN REVISION TOTAL HIP ARTHROPLASTY: HIGH SURVIVAL RATES AND ENHANCED FUNCTIONAL RESULTS WITH REINFORCEMENT CONSTRUCTS. J ARTHROPLASTY. 2025 APR 25:S0883-5403(25)00381-X. DOI: 10.1016/J.ARTH.2025.04.044. EPUB AHEAD OF PRINT. PMID: 40288502. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE SURVIVORSHIP OF CEMENTED MONOBLOC DUAL MOBILITY CUPS (MDMC) IN REINFORCEMENT CONSTRUCTS IN REVISION TOTAL HIP ARTHROPLASTY (RTHA). BETWEEN JANUARY 1, 2010, AND DECEMBER 31, 2019, A TOTAL OF 59 PATIENTS (21 MALE AND 38 FEMALE; MEAN AGE WAS 69 YEARS; THE MEAN BMI WAS 26.1) WHO UNDERWENT RTHA WITH A CEMENTED MDMC (NOVAE STICK (SERF® - DECINES, FRANCE) COMBINED WITH AN ACETABULAR REINFORCEMENT CONSTRUCT, WITH A MINIMUM FOLLOW-UP OF FIVE YEARS, WERE INCLUDED IN THE STUDY. THE ACETABULAR REINFORCEMENTS USED INCLUDED THE KERBOULL CROSS-PLATE (26 CASES, 44.1%), THE BURCH-SCHNEIDER ANTIPROTRUSION CAGE (16 CASES, 27.1%), THE GRIPTION TF AUGMENT (EIGHT CASES, 13.6%), THE CUP-IN-CUP TECHNIQUE (SIX CASES, 10.1%), THE PINNACLE ACETABULAR CUP SYSTEM (TWO CASES, 3.4%), AND CUSTOM-MADE POROUS TITANIUM IMPLANTS FOR LARGE PELVIC BONE LOSS RECONSTRUCTION (ONE CASE, 1.7%). ADDITIONALLY, FEMORAL HEAD OR CHIP ALLOGRAFTS WERE IMPACTED AT THE SITE IN 35 CASES (59.4%). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES PINNACLE ACETABULAR CUP. OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: NOVAE STICK (SERF®) AND PALACOS R+G (HERAEUS MEDICAL GMBH). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CONSTRUCT PINNACLE (QTY 1): (N=1) INFECTION; INTERVENTION NOT SPECIFIED, BUT ARTICLE STATED "THE REVISED CASES DUE TO INFECTION WERE TREATED WITH THE DAIR (DEBRIDEMENT, ANTIBIOTICS, IMPLANT RETENTION) PROCEDURE, IRRIGATION, AND POLYETHYLENE INSERT-FEMORAL HEAD EXCHANGE WITH SUBSEQUENT ADMINISTRATION OF SIX WEEKS OF IV AND AN ADDITIONAL SIX WEEKS OF ORAL ANTIBIOTICS. CLEARANCE OF INFECTION WAS VERIFIED BY THE ABSENCE OF RELEVANT SIGNS OR SYMPTOMS DURING THE FOLLOW-UP PERIOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448524 UNKNOWN HIP ACETABULAR CONSTRUCT PINNACLE PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention