BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA LINERS & ACCESSORIES

    MDR report key: 24531029 · Received March 6, 2026

    Report

    Report Number
    3008021110-2026-00129
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    January 9, 2026
    Report Date
    March 6, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    LPH
    UDI-DI
    08033390136105
    PMA / PMN Number
    K182099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW-UP COMMUNICATION IT WAS LEARNED THAT DURING SURGERY ALSO THE ORIGINAL FEMORAL STEM WAS REMOVED AND REPLACED WITH ANOTHER ONE FROM A DIFFERENT MANUFACTURER, HOWEVER THE REASON FOR THE REVISION REMAINS UNKNOWN. REVIEW OF MANUFACTURING AND STERILIZATION RECORDS FOR INVOLVED BATCH OF LINER DID NOT HIGHLIGHT ANY PRE-EXISTING ANOMALY OR NON-CONFORMITY. COMPLAINT DATABASE REVIEW DID NOT IDENTIFY ANY FURTHER COMPLAINT FOR INVOLVED LOTS. EXPLANTED COMPONENTS HAVE BEEN DISCARDED AND NO X-RAYS TO FURTHER INVESTIGATE ARE AVAILABLE. HENCE, TAKING INTO ACCOUNT THAT: - NO ANOMALIES WERE IDENTIFIED IN DHR, - NO FURTHER COMPLAINTS WERE REPORTED ON INVOLVED LOT, THE MANUFACTURER HAS NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. BASED ON THE AVAILABLE PMS DATA, THE REVISION RATE OF DELTA LINERS, BELONGING TO THE FAMILY PRODUCT CODES 5885.54.XXX IS AROUND (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.

    Description of Event or Problem · 0

    REVISION SURGERY OF HIP PROSTHESIS WAS PERFORMED ON (B)(6) 2026 DUE TO UNKNOWN REASON. ORIGINAL SURGERY OCCURRED ON (B)(6) 2023 TO IMPLANT THE FOLLOWING COMPONENTS: - DELTA TT ACETABULAR CUP DIA52MM (PN 5553.14.523, LOT 2216711, STERILIZATION (B)(4)) - DELTA NEUTRAL LINER #MEDIUM (PN 5885.54.259, LOT 2112535, STERILIZATION (B)(4)) - MASTERSL LATERALIZED HIP STEM (PN 3516.21.220, LOT 2221511, STERILIZATION (B)(4)) - BIOLOX DELTA FEMORAL HEAD MEDIUM TAPER=12/14 (PN 5010.42.362, LOT 2283891, STERILIZATION (B)(4)). DURING REVISION THE SURGEON REPLACED THE PRE-EXISTING LINER WITH A NEW ONE (PN 5887.54.259). SURGERY WAS COMPLETED AS INTENDED. THE PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1943. THE EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110713 DELTA LINERS & ACCESSORIES NEUTRAL LIMAVIT LINER I.D. 36MM, SIZE MEDIUM+ LPH LIMACORPORATE S.P.A 5885.54.259 2112535 08033390136105

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention