BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BI-MENTUM HIP ACETABULAR LINER - PATIENT FACTORS

    MDR report key: 21225804 · Received January 23, 2025

    Report

    Report Number
    3008668801-2025-00023
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    October 17, 2023
    Report Date
    February 6, 2026
    Manufacturer
    S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION
    Product Code
    MEH
    PMA / PMN Number
    K181744
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING PATIENT FACTORS INVOLVING AN UNKNOWN BI-MENTUM HIP ACETABULAR LINER WAS REPORTED. CONCLUSIONS: THE REPORTED DEVICE IS AN SERF PRODUCT. THE PRODUCTS WERE NOT RETURNED, NO PRODUCT FOR INVESTIGATION CAN BE PERFORMED. NO X RAY HAS BEEN PROVIDED, NO INFORMATION. DOCUMENTARY REVIEW IS NOT APPLICABLE IN THE ABSENCE OF BATCH NUMBERS. FURTHERMORE, DEVICES CANNOT BE IDENTIFIED IN THE ABSENCE OF REFERENCES. SERF DOES NOT HAVE THE INFORMATION NECESSARY TO DETERMINE THE CAUSE OF THE EVENTS. SERF HAS NO EVIDENCE TO DETERMINE THE CAUSE OF THE COMPLAINT. THESE LISTED EVENTS CANNOT BE INVESTIGATED AND MAY BE CAUSED BY SEVERAL FACTORS THAT CANNOT BE DEMONSTRATED DUE TO LACK OF INFORMATION. THE CAUSE CANNOT BE CONFIRMED."

    Description of Event or Problem · 0

    (B)(4): SERF RC-23-0176 "PINNACLE DUAL MOBILITY DATA WAS REVIEWED VIA DATA USE AGREEMENTS WITH MULTIPLE SURGEONS ACROSS MULTIPLE SITES. THE FOLLOWING POST-OPERATIVE ADVERSE EVENTS WERE IDENTIFIED.(B)(6) MEDICAL CENTER 4 INCIDENTS OF CALF SWELLING, INTERVENTION UNKNOWN 2 EMERGENCY DEPARTMENT VISITS, NO FURTHER INFORMATION 4 GROIN PAIN/CATCHING, INTERVENTION UNKNOWN 1 IT BAND TENDONITIS, INTERVENTION UNKNOWN 2 PAIN AT THE INCISION SITE, INTERVENTION UNKNOWN 1 SCIATICA, INTERVENTION UNKNOWN 3 SURGICAL SITE DRAINING, INTERVENTION UNKNOWN (B)(6) HOSPITAL 1 DEEP PERIPROSTHETIC INFECTION REQUIRING REVISION 1 INTERPROSTHETIC DISLOCATION REQUIRING REVISION 1 LOW BACK AND HIP PAIN, INTERVENTION UNKNOWN INFORMATIONS (B)(6): I AM WORKING ON A PROJECT THAT INVOLVES COLLECTING PINNACLE DUAL MOBILITY DATA VIA DATA USE AGREEMENTS WITH MULTIPLE SURGEONS AT DIFFERENT LOCATIONS. UPON REVIEW OF RECENTLY SUBMITTED DATA, IT WAS NOTED TWENTY-ONE ADVERSE EVENTS AND TWO REVISIONS WERE REPORTED BY TWO SURGEONS ¿ I¿VE INCLUDED THEM IN THE ATTACHED SPREADSHEET. NOTE: THE REPORTED DATA IS SUMMARIZED AND I HAVE NO VISIBILITY TO IMPLANT DETAILS OR ANY PATIENT INFORMATION RELATED TO INDIVIDUAL ADVERSE EVENTS."

    Description of Event or Problem · 0

    (B)(4): SERF RC-23-0176 "PINNACLE DUAL MOBILITY DATA WAS REVIEWED VIA DATA USE AGREEMENTS WITH MULTIPLE SURGEONS ACROSS MULTIPLE SITES. THE FOLLOWING POST-OPERATIVE ADVERSE EVENTS WERE IDENTIFIED. MERCY MEDICAL CENTER 4 INCIDENTS OF CALF SWELLING, INTERVENTION UNKNOWN 2 EMERGENCY DEPARTMENT VISITS, NO FURTHER INFORMATION 4 GROIN PAIN/CATCHING, INTERVENTION UNKNOWN 1 IT BAND TENDONITIS, INTERVENTION UNKNOWN 2 PAIN AT THE INCISION SITE, INTERVENTION UNKNOWN 1 SCIATICA, INTERVENTION UNKNOWN 3 SURGICAL SITE DRAINING, INTERVENTION UNKNOWN SAINT PETERS COMMUNITY HOSPITAL 1 DEEP PERIPROSTHETIC INFECTION REQUIRING REVISION 1 INTERPROSTHETIC DISLOCATION REQUIRING REVISION 1 LOW BACK AND HIP PAIN, INTERVENTION UNKNOWN. INFORMATIONS COMPLÉMENTAIRES DE - STAFF CLINICAL RESEARCH SCIENTIST DEPUY SYNTHES: I AM WORKING ON A PROJECT THAT INVOLVES COLLECTING PINNACLE DUAL MOBILITY DATA VIA DATA USE AGREEMENTS WITH MULTIPLE SURGEONS AT DIFFERENT LOCATIONS. UPON REVIEW OF RECENTLY SUBMITTED DATA, IT WAS NOTED TWENTY-ONE ADVERSE EVENTS AND TWO REVISIONS WERE REPORTED BY TWO SURGEONS ¿ I¿VE INCLUDED THEM IN THE ATTACHED SPREADSHEET. NOTE: THE REPORTED DATA IS SUMMARIZED AND I HAVE NO VISIBILITY TO IMPLANT DETAILS OR ANY PATIENT INFORMATION RELATED TO INDIVIDUAL ADVERSE EVENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556214 UNKNOWN BI-MENTUM HIP ACETABULAR LINER - PATIENT FACTORS PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R