BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK PROSTALAC HIP FEMORAL STEM

    MDR report key: 21855070 · Received April 17, 2025

    Report

    Report Number
    1818910-2025-05850
    Event Type
    Injury
    Date Received
    April 17, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    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: HECKMANN ND, WANG JC, RICHARDSON MK, BIEDERMANN BM, DIGIOVANNI RM, CHRIST AB, LONGJOHN DB, OAKES DA. CEMENTED CONSTRAINED LINERS USED AS AN ARTICULATING HIP SPACER FOR THE TREATMENT OF CHRONIC PROSTHETIC JOINT INFECTION. ARTHROPLAST TODAY. 2024 AUG 10;29:101422. DOI: 10.1016/J.ARTD.2024.101422. PMID: 39224754; PMCID: PMC11367267. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO EVALUATE THE LONG-TERM STABILITY OF A SINGLE MANUFACTURER CONSTRAINED-LINER DESIGN USED AS PART OF AN ARTICULATING HIP SPACER CONSTRUCT FOR THE TREATMENT OF PERIPROSTHETIC JOINT INFECTION (PJI). BETWEEN JANUARY 2013 TO JUNE 2022, A TOTAL OF 26 CONSTRAINED LINERS WERE UTILIZED IN 25 PATIENTS FOR THE PURPOSE OF AN ARTICULATING SPACER WERE INCLUDED IN THE STUDY. OF THESE, 16 PATIENTS (61.5%) WERE WOMEN WITH AN AVERAGE AGE OF 67.8 (RANGE: 37-91). ALL ARTICULATING HIP SPACERS UTILIZING A SINGLE CONSTRAINED LINER DESIGN (FREEDOM CONSTRAINED LINER, ZIMMER BIOMET, WARSAW, IN) WAS USED. REGARDING FEMORAL COMPONENTS, A PROSTALAC (DEPUY, WARSAW, IN) IMPLANT WAS UTILIZED IN 20 CASES, A BIOMET (ZIMMER BIOMET, WARSAW, IN) CEMENTED IMPLANT IN 5 CASES, AND TJO (TOTAL JOINT ORTHOPEDICS, SALT LAKE CITY, UT) IMPLANT IN ONE CASE. THE AVERAGE FOLLOW-UP WAS 28.3 MONTHS (RANGE: 0.7-106.0). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES PROSTALAC IMPLANT. OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: FREEDOM CONSTRAINED LINER (ZIMMER BIOMET). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK PROSTALAC HIP FEMORAL STEM (QTY 1): - (N=1) EXPERIENCE MULTIPLE REVISIONS RELATED TO A PERIPROSTHETIC TROCHANTERIC FRACTURE, WHICH WERE ADDRESSED VIA REPLACEMENT OF THE FEMORAL PROSTALAC ONLY WHILE THE FEMORAL HEAD AND ACETABULAR COMPONENTS REMAINED INTACT WITHOUT LOOSENING FOR MORE THAN 55 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682137 UNK PROSTALAC HIP FEMORAL STEM PROSTALAC HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention