BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 9121481 · Received September 25, 2019

    Report

    Report Number
    1818910-2019-106306
    Event Type
    Injury
    Date Received
    September 25, 2019
    Date of Event
    March 21, 2013
    Report Date
    September 6, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (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 RECEIVED ENTITLED "LOW RATE OF DISLOCATION OF DUAL-MOBILITY CUPS IN PRIMARY TOTAL HIP ARTHROPLASTY". LITERATURE ARTICLE ENTITLED, ¿LOW RATE OF DISLOCATION OF DUAL-MOBILITY CUPS IN PRIMARY TOTAL HIP ARTHROPLASTY¿ BY ANTOINE COMBES MD, ET AL, PUBLISHED BY CLINICAL ORTHOPAEDIC RELATED RESEARCH (2013), PUBLISHED ONLINE AT DOI 10.1007/S11999-013-2929-3 WAS REVIEWED FOR MDR REPORTABILITY. THIS ARTICLE IS THE STUDY OF (1) THE DISLOCATION RATE, (2) LOOSENING AND OSTEOLYSIS, AND (3) SUBSEQUENT RELATED REVISIONS WITH DUAL MOBILITY (DM) CUPS. BETWEEN 1998 AND 2003, 2480 PRIMARY THAS WITH DM CUPS WERE UNDERTAKEN IN 2179 PATIENTS. THE MEAN AGE WAS (B)(6) (RANGE, 19¿94 YEARS). THIS GROUP UNDERWENT SPECIFIC CLINICAL AND RADIOGRAPHIC EVALUATION AT A MINIMUM FOLLOW-UP OF 0.17 YEARS (MEAN, 7 YEARS; RANGE, 0.17¿11 YEARS) TO ASSESS DISLOCATION, REOPERATION, OSTEOLYSIS, AND CUP FIXATION. ALL PATIENTS RECEIVED HEMISPHERICAL DM CUPS. N 756 GYROS (DEPUY) AND EIGHT OTHER COMPETITOR PRODUCTS WERE IMPLANTED. ALL OF THESE IMPLANTS CONSISTED OF A METALLIC SHELL (3 MM THICK), INCLUDING A MOBILE POLYETHYLENE INSERT (ARTICULATED WITH THE METALLIC SHELL), ALL OF UNKNOWN MANUFACTURER. THE POLYETHYLENE INSERT WAS HEMISPHERICAL, OF ULTRAHIGH MOLECULAR WEIGHT (NOT CROSSLINKED). THE DIAMETER OF THE SMALL ARTICULATION WAS 22 MM IN 1372 HIPS, 28 MM IN 2018 HIPS, AND UNKNOWN IN 84 HIPS. THE INSERT WAS ARTICULATED WITH THE FEMORAL HEAD AFTER IT WAS IMPACTED BY FORCE OVER A POLYETHYLENE RIM DESIGNED FOR RETENTION. THE METALLIC SHELL WAS MADE OF STAINLESS STEEL (N = 3055, 87%) OR COBALT-CHROMIUM (N = 419, 13%). THERE WERE 22 DISLOCATIONS AMONG 2480 HIPS (0.88%): 15 DISLOCATIONS OF THE LARGE ARTICULATION (0.6%) AND SEVEN DISLOCATIONS OF THE SMALL ARTICULATION (0.28%). AMONG THE 15 LARGE-ARTICULATION DISLOCATIONS (0.6%), ONLY ONE WAS REVISED FOR RECURRENT DISLOCATION (0.04%). TWELVE LARGE-ARTICULATION DISLOCATIONS (0.48%) OCCURRED WITHIN 3 MONTHS AFTER THE INDEX PROCEDURE AND DID NOT RECUR. THREE LARGE-ARTICULATION DISLOCATIONS OCCURRED BEYOND 3 MONTHS AFTER INSERTION: TWO (0.08%) RECURRED (ONE HIP HAD ONE RECURRENCE, AND ONE HIP HAD TWO RECURRENCES, LEADING TO THE PREVIOUSLY MENTIONED REVISION TO CORRECT CUP MALPOSITION WITH A NEW DM CUP AND WITHOUT RECURRENCE) AND THE THIRD ONE OCCURRED AT 6 YEARS AFTER INSERTION WITHOUT RECURRENCE. OSTEOLYSIS WAS IDENTIFIED ON SEQUENTIAL RADIOGRAPHS IN 145 HIPS (6%): ACETABULAR OSTEOLYSIS IN 91 HIPS (3.8%), FEMORAL OSTEOLYSIS IN 78 HIPS (3.2%), AND COMBINED FEMORAL AND ACETABULAR OSTEOLYSIS IN 24 HIPS (1%). THIRTY-ONE CUPS WERE REVISED DUE TO LOOSENING AFTER A MEAN FOLLOW-UP OF 6 ± 2 YEARS (RANGE, 1.5¿10 YEARS). FIFTY-THREE HIPS (2%) HAD ISOLATED ANTERIOR PAIN ON HIP FLEXION IN THE SUPINE POSITION, WHICH SUGGESTED CLINICAL ILIOPSOAS IRRITATION. AMONG THESE 53 HIPS, 30 HIPS HAD HARRIS HIP SCORES OF 40 POINTS, 16 HIPS 30 POINTS, AND SEVEN HIPS 20 POINTS, INDICATING NO HIPS HAD SEVERE PAIN. FIVE REVISIONS WERE PERFORMED WITH CUP EXCHANGE FOR ANTERIOR PAIN. THE AUTHORS DID NOT DIFFERENTIATE HARMS AND ADVERSE EVENTS WITH SPECIFIC PRODUCT LINES. IN TOTAL, 31 ACETABULAR COMPONENTS WERE REVISED FOR THE REASONS LISTEN IN THE EVENT DESCRIPTION. OSTEOLYSIS WAS CONFIRMED WITH SERIAL RADIOGRAPHIC STUDIES AND IS THEREFORE REPORTABLE. THE POLYETHYLENE LINERS, FEMORAL HEADS, AND FEMORAL STEMS WERE NOT IDENTIFIED WITHIN THE TEXT OF THE ARTICLE. IN TOTAL, THERE WERE 726 DEPUY IMPLANTS UTILIZED WITHIN THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915104 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention