BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK HIP FEMORAL STEM CORAIL

    MDR report key: 12349236 · Received August 20, 2021

    Report

    Report Number
    1818910-2021-18296
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    December 1, 2020
    Report Date
    August 7, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY:NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). WHERE THE LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITERATURE ARTICLE ENTITLED, ¿THE EFFECT OF FEMORAL STEM COLLAR ON IMPLANT MIGRATION AND CLINICAL OUTCOMES FOLLOWING DIRECT ANTERIOR APPROACH TOTAL HIP ARTHROPLASTY: A RANDOMIZED TRIAL,¿ BY M. E. PERELGUT, ET. AL., PUBLISHED BY THE BONE AND JOINT JOURNAL (2020), VOL. 102-B, NO. 12, 11, 1654-1661 WAS REVIEWED. THE PURPOSE OF THIS RADIOSTEREOMETRIC (RSA) STUDY WAS TO DETERMINE WHETHER THE ADDITION OF A COLLAR TO THE FEMORAL STEM AFFECTS IMPLANT MIGRATION, PATIENT ACTIVITY, AND PATIENT FUNCTION FOLLOWING PRIMARY THA USING THE DA APPROACH. THE AUTHORS STUDIED 49 PATIENTS IMPLANTED WITH PRIMARY UNILATERAL DEPUY PINNACLE/CORAIL MOP THA - 23 RECEIVED A COLLARED STEM AND 26 RECEIVED A COLLARLESS STEM BETWEEN JANUARY 2018 AND JULY 2019 AND RECEIVED CONSECUTIVE RSA STUDIES TO DETERMINE IF THE COLLARS AFFECTED THE AMOUNT OF STEM MIGRATION WITHIN ONE YEAR. THERE WERE NO COMPLICATIONS, ADVERSE EVENTS, OR REVISIONS AT ONE YEAR FOLLOW-UP. THE MAJORITY OF THE STEM SUBSIDENCE OCCURRED WITHIN THE FIRST TWO WEEKS. NONE OF THE REPORTED STEM SUBSIDENCE REQUIRED A SURGICAL INTERVENTION OR TREATMENT. PATIENT SPECIFIC RESULTS: 1 MALE SIZE 11 COLLARLESS STEM WITH 7.15MM SUBSIDENCE. 1 FEMALE PATIENT SIZE 12 COLLARLESS STEM WITH 11.12MM SUBSIDENCE. 1 FEMALE PATIENT SIZE 9 COLLARLESS STEM WITH 11.51MM SUBSIDENCE. 1 MALE SIZE 16 COLLARLESS STEM WITH 8.57MM SUBSIDENCE. NON-PATIENT SPECIFIC RESULTS: UNKNOWN NUMBER OF COLLARED AND COLLARLESS WITH SUBSIDENCE LESS THAN 5MM. 4 COLLARLESS STEMS ROTATED INTO RETROVERSION- NO TREATMENT NECESSARY. 4 COLLARLESS STEMS ROTATED INTO MORE THAN 2 DEGREES VALGUS- NO TREATMENT NECESSARY. CAPTURED IN THIS COMPLAINT: CORAIL COLLARLESS STEM: IMPLANT MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244607 UNK HIP FEMORAL STEM CORAIL FEMORAL STEM LPH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1