BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK HIP ACETABULAR CUP PINNACLE

    MDR report key: 12546453 · Received September 29, 2021

    Report

    Report Number
    1818910-2021-21346
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    May 24, 2020
    Report Date
    September 10, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. EXAMINATION OF ALL PATIENT X-RAYS CONTAINED IN THE PROVIDED LITERATURE ARTICLE WAS CONDUCTED. AFTER REVIEWING A PROGRESSIVE SERIES OF X-RAYS THE INVESTIGATION IDENTIFIED MIGRATION OF THE RIGHT ACETABULAR CUP. IT IS NOTED THAT THE PATIENT HAD A PATHOLOGICAL ACETABULAR FRACTURE AFTER IRRADIATION TREATMENT FOR CANCER. IT IS POSSIBLE THAT THE PATIENT HAD LESS THAN OPTIMAL BONE QUALITY BEFORE IMPLANTATION. THE INVESTIGATION DID NOT IDENTIFY PRODUCT ERROR ASSOCIATED WITH THE MIGRATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : A DEVICE HISTORY RECORD (MRE) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    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

    ARTICLE ENTITLED ¿REVERSE REAMING DISTRACTION FOR ACETABULAR RECONSTRUCTION OF CHRONIC PELVIC DISCONTINUITY" WRITTEN BY JING-YANG SUN, MING NI, HAI-YANG MA, YIN-QIAO DU, JUN-MIN SHEN, JI-YING CHEN, YONG-GANG ZHOU, AND GUO-GIANG ZHANG, PUBLISHED BY JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH, 24 MAY 2020, WAS REVIEWED. THE AIM OF THIS STUDY IS TO DESCRIBE A MODIFIED DISTRACTION TECHNIQUE AND TO SHOW OUR RESULTS. THE ACETABULAR DISTRACTION TECHNIQUE DEMONSTRATES ENCOURAGING RADIOGRAPHIC AND CLINICAL OUTCOMES IN TREATING CHRONIC PELVIC DISCONTINUITY. THIS STUDY IDENTIFIED 12 CASES OF CHRONIC PELVIC DISCONTINUITY UNDERGOING PRIMARY OR REVISION TOTAL HIP ARTHROPLASTY (THA) WITH THE TECHNIQUE OF REVERSE REAMING DISTRACTION BETWEEN JULY 2015 AND NOVEMBER 2018. ALL 12 PATIENTS HAD A MINIMUM FOLLOW-UP OF 12 MONTHS. RADIOGRAPHS WERE REVIEWED TO INSPECT FOR COMPONENT LOOSENING. CLINICAL ASSESSMENT INCLUDED THE HARRIS HIP SCORE (HHS) AND AN AMBULATORY SCORING SYSTEM. AT THE TIME OF FINAL FOLLOW-UP, NO PATIENT WAS REVISED. ONE PATIENT HAD UP TO 1 CM MIGRATION OF THE CUP IN A HORIZONTAL OR VERTICAL DIRECTION AND MORE THAN 20° CHANGE IN THE ABDUCTION ANGLE BUT WAS ASYMPTOMATIC. IN THE REMAINING 11 PATIENTS, NO MIGRATION OF THE COMPONENT WAS DETECTED. BOTH THE HHS AND AMBULATORY SCORE SHOWED IMPROVEMENT IN ALL PATIENTS. THERE WERE NO PERIOPERATIVE COMPLICATIONS. NO POSTOPERATIVE DISLOCATION OCCURRED. IT WAS CONCLUDED THAT REVERSE REAMING DISTRACTION IS A FEASIBLE TECHNIQUE IN TREATMENT OF CHRONIC PELVIC DISCONTINUITY, WITH ENCOURAGING RESULTS AT EARLY TERM. HOWEVER, ONGOING FOLLOW-UP IS REQUIRED TO DETERMINE THE LONG-TERM PROGNOSIS IN PATIENTS RECEIVING THIS TECHNIQUE. ADVERSE EVENTS NOTED IN THIS ARTICLE INCLUDED: ACETABULAR MIGRATION/ ACETABULAR CUP LOOSENING AT BONE/IMPLANT INTERFACE. THIS STUDY INCLUDED COMPETITOR HIPS, AS WELL AS DEPUY PINNACLE GRIPTION CUP. THERE WAS NO INDICATION PROVIDED AS TO WHICH HIP HAD THE MIGRATION ISSUE, SO IT WILL BE REPORTED AS DEPUY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447551 UNK HIP ACETABULAR CUP PINNACLE HIP ACETABULAR CUP JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown