BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP ACETABULAR CONSTRUCT P

    MDR report key: 24765194 · Received April 2, 2026

    Report

    Report Number
    1818910-2026-05759
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    October 14, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    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. 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. DEVICE HISTORY LOT: THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TAUNTON MJ, FEHRING TK, EDWARDS P, BERNASEK T, HOLT GE, CHRISTIE MJ. PELVIC DISCONTINUITY TREATED WITH CUSTOM TRIFLANGE COMPONENT: A RELIABLE OPTION. CLIN ORTHOP RELAT RES. 2012 FEB;470(2):428-34. DOI: 10.1007/S11999-011-2126-1. PMID: 21997785; PMCID: PMC3254733. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY IS TO DETERMINE REVISION AND OVERALL SURVIVAL RATES, (2) DISCONTINUITY HEALING RATE, AND HARRIS HIP SCORE (HHS) AFTER TREATMENT OF PELVIC DISCONTINUITY WITH A CUSTOM TRIFLANGE ACETABULAR COMPONENT AND THE COST OF THIS RECONSTRUCTIVE OPERATION COMPARED TO OTHER CONSTRUCTS. A TOTAL OF 57 PATIENTS (51 WOMEN AND SIX MEN) WITH PELVIC DISCONTINUITY TREATED WITH REVISION THA USING A CUSTOM TRIFLANGE ACETABULAR COMPONENT (PINNACLETM TRIFLANGE ACETABULAR SYSTEM (DEPUY ORTHOPAEDICS, INC, WARSAW, IN, USA). THE MINIMUM FOLLOWUP WAS 24 MONTHS (AVERAGE, 65 MONTHS; RANGE, 24¿215 MONTHS). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: PINNACLE TRIFLANGE ACETABULAR SYSTEM ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CONSTRUCT PINNACLE (QTY 35). N=20; HAD REVISION FOR ANY REASON. N=2; DEEP INFECTION - RESECTION OF THE ACETABULAR COMPONENT. N=2; SUPERFICIAL SEROMAS - REOPERATION. N=1; SCIATIC PALSY - NERVE EXPLORATION. N=10; NO OBVIOUS HEALING OF THE DISCONTINUITY . ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CUP PINNACLE (QTY 13). N=1; ASEPTIC LOOSENING (11 YEARS POST SURGERY) - REVISION. N=9; MIGRATION OF AT LEAST A PART OF THE TRIFLANGE ACETABULAR COMPONENT. N=3; ISCHIAL SCREW MIGRATION - NO INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170519 UNK HIP ACETABULAR CONSTRUCT P PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention