BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 9158042 · Received October 4, 2019

    Report

    Report Number
    1818910-2019-107686
    Event Type
    Injury
    Date Received
    October 4, 2019
    Date of Event
    May 25, 2016
    Report Date
    September 17, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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 NULL. DEVICE HISTORY BATCH NULL. DEVICE HISTORY REVIEW NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE ENTITLED, ¿DIFFERENCES IN SUBSIDENCE RATE BETWEEN ALTERNATIVE DESIGNS OF A COMMONLY USED UNCEMENTED FEMORAL STEM¿ BY MUNNAN AL-NAJJIM, ET AL, PUBLISHED BY THE JOURNAL OF ORTHOPAEDICS (2016), VOL. 13, PP. 322-326, WAS REVIEWED FOR MDR REPORTABILITY. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE FACTORS ASSOCIATED WITH SUBSIDENCE IN COLLARED AND UNCOLLARED VERSIONS OF THE CORAIL (DEPUY) FEMORAL STEM. BETWEEN AUGUST 2007 AND FEBRUARY 2010, 135 UNCEMENTED TOTAL HIP REPLACEMENTS WERE PERFORMED USING THE CORAIL FEMORAL STEMS AND PINNACLE ACETABULAR COMPONENT (CORAIL; DEPUY) IN 121 HIPS (113 PATIENTS). FIFTY-FIVE HIP REPLACEMENTS (51 PATIENTS) WERE ALLOCATED TO THE COLLARLESS GROUP, AND 66 HIP REPLACEMENTS (62 PATIENTS) WERE ALLOCATED TO THE COLLARED GROUP. THERE WAS NO LOSS TO FOLLOW UP IN THESE PATIENTS. COMBINING THE TWO GROUPS, 9% HIP REPLACEMENTS (11/121) SHOWED RADIOGRAPHIC EVIDENCE OF SUBSIDENCE AT 1-YEAR FOLLOW UP. MAJORITY OF THE SUBSIDENCE WAS FOUND TO HAVE OCCURRED WITHIN THE FIRST 6¿8 WEEKS IN BOTH GROUPS. 7.6% (5/66) IMPLANTS IN THE COLLARED GROUP AND 10.9% (6/55) IMPLANTS IN THE COLLARLESS GROUP SHOWED SUBSIDENCE WITHIN THE 6¿8 WEEKS. AFTER THIS STAGE, 2 PATIENTS HAD FURTHER SUBSIDENCE OF IMPLANTS AND UNDERWENT REVISION AT 13 MONTHS FOR THE COLLARED STEM AND 36 MONTHS FOR THE COLLARLESS STEM AFTER PRIMARY SURGERY. NO FURTHER SUBSIDENCE WAS SEEN IN THE REMAINING SUBSIDED IMPLANTS IN BOTH GROUPS. THE OPERATIVE COMPLICATIONS WERE AS FOLLOWS: 5 SURGICAL SITE INFECTIONS, 4 CASES OF DVT, 2 CUP REVISIONS FOR UNSPECIFIED REASONS, AND ONE IATROGENIC FRACTURE. THE AUTHORS DO NOT IDENTIFY PATIENTS WITH SPECIFIC ADVERSE EVENTS. THE AUTHORS DO NOT NOTE THE REASON FOR THE CUP REVISIONS. THE SIZE AND MANUFACTURER IS NOT IDENTIFIED BY THE AUTHORS, IT IS ASSUMED TO BE A DEPUY PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952892 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD KWY DEPUY ORTHOPAEDICS, INC. 1818910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention