BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA TT PRO

    MDR report key: 23942996 · Received January 2, 2026

    Report

    Report Number
    3008021110-2025-00174
    Event Type
    Injury
    Date Received
    January 2, 2026
    Date of Event
    November 24, 2025
    Report Date
    January 2, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    LPH
    UDI-DI
    08033390146043
    PMA / PMN Number
    K182099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REVIEW OF MANUFACTURING AND STERILIZATION RECORDS DID NOT IDENTIFY ANY PRE-EXISTING ANOMALY THAT COULD HAVE CONTRIBUTED TO REPORTED ISSUE. THROUGH FOLLOW-UP COMMUNICATION (23.12.2025), IT WAS LEARNED THAT THE ACETABULAR CUP WAS FOUND LOOSE AND MOST LIKELY OSSEOINTEGRATION DID NOT OCCUR AS EXPECTED. ACCORDING TO INFORMATION PROVIDED BY COMPLAINT SOURCE, NO PATIENT CLINICAL CONDITIONS NOR MALPRACTICE COULD HAVE CONTRIBUTED TO REPORTED ISSUE. COMPONENTS INVOLVED WERE DISCARDED AND NO X-RAYS COULD BE PROVIDED TO FURTHER INVESTIGATE THE PARTS. COMPLAINT DATABASE REVIEW REVEALED NO SIMILAR EVENTS FOR INVOLVED LOT OF DELTA TT ACETABULAR CUP. HENCE, TAKING INTO ACCOUNT THAT: NO PRE-EXISTING ANOMALIES WERE FOUND IN MANUFACTURING RECORDS POSSIBLY RELATED TO REPORTED ISSUE, NO OTHER COMPLAINT HAS BEEN REPORTED ON THE SAME BATCH OF ACETABULAR CUP FROM THE MARKET, THE MANUFACTURER HAS NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA: BASED ON THE AVAILABLE PMS DATA, THE REVISION RATE OF DELTA TT PRO ACETABULAR CUPS, BELONGING TO THE FAMILY PRODUCT CODES 5553.14.XXX, (B)(4). ACCORDING TO THE INVESTIGATION CARRIED OUT, NO CORRECTIVE ACTION IS NEEDED FOR THIS EVENT. THE MANUFACTURER WILL CONTINUE MONITORING THE MARKET IN ORDER TO DETECT ANY SIMILAR EVENT. NOTE: THIS IS A COMBINED INITIAL FINAL REPORT.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO NON UNION OF THE HIP PROSTHESIS. ACCORDING TO INFORMATION PROVIDED BY COMPLAINT SOURCE, THE PERFORMANCE ISSUE WAS REPORTED ON THE ACETABULAR SIDE OF THE PROSTHETIC ASSEMBLY. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2021, AND FOLLOWING COMPONENTS WERE IMPLANTED: DELTA TT PRO D50MM MEDIUM+ ACETABULAR CUP (PART NUMBER 5553.14.503, LOT 2117019, STERILIZATION 2100278), DELTA NEUTRAL LINER D36MM #M (PART NUMBER 5885.54.259, LOT 2107883, STERILIZATION 2100206), MASTER SL STEM #5 (PART NUMBER 3515.21.250, LOT 2022664, STERILIZATION 2100029), FEMORAL MODULAR HEAD S - DIA36MM (PART NUMBER 5010.42.361, LOT 2183087, STERILIZATION 2100217). DURING REVISION SURGERY, THE LIMA PROSTHETIC COMPONENTS WERE EXPLANTED AND REPLACED WITH EMPOWR ACETABULAR SYSTEM AND BONE SCREWS. ALSO THE CERAMIC FEMORAL HEAD HAS BEEN REPLACED WITH THE EMPOWR ONE FOR COMPATIBILITY REASONS, WHILE THE FEMORAL STEM REMAINED IN PLACE SINCE NO PROBLEMS WITH THAT COMPONENT WERE FOUND BY SURGEON. SURGERY HAS BEEN COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1951. THE EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5571 DELTA TT PRO ACETABULAR CUP (TI6AL4V) DIA. 50 MM, FOR LINERS SIZE MEDIUM + LPH LIMACORPORATE S.P.A 5553.14.503 2117019 08033390146043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention