BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 8878675 · Received August 9, 2019

    Report

    Report Number
    1818910-2019-100641
    Event Type
    Injury
    Date Received
    August 9, 2019
    Date of Event
    January 9, 2019
    Report Date
    July 30, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, 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

    (B)(4). LITERATURE ARTICLE ENTITLED, ¿THREE- TO SIX-YEAR RESULTS WITH THE ULTIMA METAL-ON-METAL ARTICULATION FOR TOTAL HIP ARTHROPLASTY,¿ BY M. JACOBS, MD, R. GORAB, MD, D. MATTINGLY, MD, L. TRICK, MD, AND C. SOUTHWORTH, MS PUBLISHED IN THE JOURNAL OF ARTHROPLASTY (2004) VOL. 19, NO. 7, SUPP. 2, PP. 48-53. (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

    PRIMARY LITERATURE ARTICLE ENTITLED, ¿THREE- TO SIX-YEAR RESULTS WITH THE ULTIMA METAL-ON-METAL ARTICULATION FOR TOTAL HIP ARTHROPLASTY,¿ BY M. JACOBS, MD, R. GORAB, MD, D. MATTINGLY, MD, L. TRICK, MD, AND C. SOUTHWORTH, MS PUBLISHED IN THE JOURNAL OF ARTHROPLASTY (2004) VOL. 19, NO. 7, SUPP. 2, PP. 48-53 WAS REVIEWED FOR MDR REPORTABILITY. THIS IS A REPORT OF THE RESULTS OF A 3-6-YEAR RANDOMIZED STUDY COMPARING THE ARTICULATION RESULTS AFTER 170 PRIMARY THA SURGERIES USING DEPUY ZTT II CEMENTLESS METAL-ON-POLYETHYLENE (MOP) ACETABULAR CUPS FOR THE 76 HIP CONTROL GROUP AND DEPUY ULTIMA CEMENTLESS METAL-ON-METAL (MOM) ACETABULAR CUPS FOR THE 95 HIP INVESTIGATIVE GROUP. ALL THAS IN THE STUDY WERE IMPLANTED WITH THE DEPUY S-ROM CEMENTLESS FEMORAL STEM AND A 28 MM COBALT-CHROME (COCR) FEMORAL HEAD. THIS STUDY GATHERS RADIOGRAPHIC DATA OF EACH PATIENT AT 6 WEEKS, 6 MONTHS, 1 YEAR, AND THEN ANNUALLY THEREAFTER. PRE- AND POSTOPERATIVE FUNCTIONAL EVALUATIONS WERE PERFORMED USING THE HARRIS HIP SCORING SYSTEM. THE AUTHORS COMPLIED THIS DATA TO COMPARE AND CONTRAST THE SUCCESSES OF THE MOM ARTICULATIONS AGAINST THAT OF THE MOP SYSTEM. THE MOM INVESTIGATIVE GROUP CONSISTED OF 46 MEN AND 49 WOMEN WITH AN AVERAGE AGE OF 53.3 YEARS. THE MOM GROUP HAD THE FOLLOWING PREOPERATIVE DIAGNOSES: 58 PATIENTS WITH OSTEOARTHRITIS, 8 PATIENTS WITH POST-TRAUMATIC ARTHRITIS, 10 PATIENTS WITH AVASCULAR NECROSIS, 6 PATIENTS WITH DEVELOPMENTAL HIP DYSPLASIA, AND 4 PATIENTS WITH NONINFLAMMATORY DIAGNOSES. THE MOP CONTROL GROUP CONSISTED OF 51 MEN AND 25 WOMEN. THE MOP GROUP HAD THE FOLLOWING PREOPERATIVE DIAGNOSES: 54 WITH OSTEOARTHRITIS, 3 WITH POST-TRAUMATIC ARTHRITIS, 16 WITH AVASCULAR NECROSIS, 3 WITH DEVELOPMENTAL DYSPLASIA, AND 0 WITH NONINFLAMMATORY DIAGNOSES. THE STUDY EXCLUDED PATIENTS WITH INFLAMMATORY ARTHRITIS AND CONSIDERED REVISION SURGERY A FAILURE OF THE PRODUCTS. THE RESULTS INDICATED AN OVERALL SUCCESS OF BOTH ARTICULATIONS AND IDENTIFIED NO MEANINGFUL DIFFERENCES BETWEEN THE MOP AND MOM ARTICULATING SURFACES. COMPLICATIONS FOR THE MOP GROUP: 15.7% OF THE PARTICIPANTS EXPERIENCED MILD-MODERATE PAIN AND 3 EXPERIENCED TROCHANTERIC BURSITIS- NO REVISIONS, CAUSATIVE FACTORS, OR MEDICAL INTERVENTION WERE GIVEN. COMPLICATIONS FOR THE MOM GROUP: 18% OF THE PARTICIPANTS EXPERIENCED MILD TO MODERATE PAIN, 15 EXPERIENCED TROCHANTERIC BURSITIS, AND 2 HAD DELAYED WOUND HEALING- NO REVISIONS, MEDICAL INTERVENTIONS, OR CAUSATIVE FACTORS WERE GIVEN. THE MOM GROUP IDENTIFIED 2 REVISIONS, ONE FOR CUP LOOSENING AFTER A TRAUMATIC ACCIDENT AND ONE FOR CHRONIC DISLOCATION. THE STUDY FOUND THAT 7 % OF THE MOP GROUP AND 12 % OF THE MOM GROUP HAD A SLIGHT LIMP AFTER SURGERY HOWEVER, THE AUTHORS COULD NOT ASSOCIATE THE PRESENCE OF A LIMP AT FOLLOW-UP WITH ANY ONE FACTOR. ADVERSE EVENT(S) RELATED TO PRODUCT(S): DISLOCATION OF THE ULTIMET METAL LINER AND COCR HEAD. CUP LOOSENING OF THE ULTIMET METAL CUP. PATIENT(S) REPORTED HARM(S): PAIN. DISLOCATION OF ULTIMET HEAD AND LINER. TROCHANTERIC BURSITIS. WOUND HEALING DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675293 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention