BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM CORAIL

    MDR report key: 12689773 · Received October 25, 2021

    Report

    Report Number
    1818910-2021-23451
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    August 10, 2021
    Report Date
    October 11, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : 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. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    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 · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MIGLIORINI F, DRIESSEN A, ESCHWEILER J, TINGART M, MAFFULLI N. NO BENEFITS OF MINIMALLY INVASIVE TOTAL HIP ARTHROPLASTY VIA WATSON-JONES APPROACH: A RETROSPECTIVE COHORT STUDY. SURGEON. 2021 AUG 10:S1479-666X(21)00129-3. DOI: 10.1016/J.SURGE.2021.07.004. EPUB AHEAD OF PRINT. PMID: 34389254. OBJECTIVE AND METHODS: "HE" PRESENT STUDY AIMED TO INVESTIGATE WHETHER A MIS APPROACH HAS A POSITIVE IMPACT ON THE OUTCOME OF THA VIA THE WATSON-JONES ANTEROLATERAL APPROACH. CLINICAL SCORES AND RADIOLOGICAL FINDINGS OF MINIMALLY AND STANDARD INVASIVE EXPOSURES WERE EVALUATED AND COMPARED. DATA FROM 140 PATIENTS (70 PATIENTS FOR EACH GROUP) WHO WERE OPERATED ON BETWEEN 2017 AND 2018 IN TWO DIFFERENT ORTHOPAEDIC INSTITUTIONS WERE ANALYZED AT TWO-YEARS FOLLOW-UP. THE PATIENT IN THE MIS GROUP RECEIVED A COMPETITOR THA. THE PATIENTS IN THE SIS GROUP RECEIVED A PINNACLE POROCOAT CUP, CORAIL HA COATED STEM, AN UNKNOWN POLYETHYLENE LINER, AND EITHER A METAL OR CERAMIC FEMORAL HEAD. THE SIS GROUP CONSISTED OF 59 WOMEN AND 11 MEN WITH A MEAN AGE OF 66.1. THE AUTHORS CONCLUDED THAT TOTAL HIP ARTHROPLASTY THROUGH THE WATSON-JONES ANTEROLATERAL APPROACH ACHIEVES EXCELLENT RESULTS AT TWO YEARS FOLLOW-UP. SURGERY PERFORMED VIA MIS PROVIDES NO SUPERIOR OUTCOME COMPARED TO THE SIS IN TERMS OF RADIOGRAPHIC FINDINGS AND PROMS. THIS COMPLAINT WILL CAPTURE THE RESULTS ASSOCIATED WITH THE SIS GROUP, AS THIS IS THE ONLY GROUP WITH DEPUY DEVICES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: PINNACLE CUP UNKNOWN HEAD UNKNOWN LINER CORAIL STEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH DEPUY DEVICES: 1 PATIENT RECEIVED A REVISION TO TREAT ASEPTIC LOOSENING OF AN UNKNOWN COMPONENT. AN UNKNOWN NUMBER OF PATIENTS REPORTED PAIN, LEG LENGTH DISCREPANCY, AND STIFFNESS ON A PATIENT SURVEY. NO TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589755 UNK HIP FEMORAL STEM CORAIL FEMORAL STEM LZO DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention