BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMAX CERAMIC INSERT 36 X 54

    MDR report key: 8473832 · Received April 2, 2019

    Report

    Report Number
    1818910-2019-89349
    Event Type
    Injury
    Date Received
    April 2, 2019
    Report Date
    March 11, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    MRA
    PMA / PMN Number
    P070026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: UPDATE (B)(6) 2022: THE INVESTIGATION WAS RE-OPENED UPON RECEIPT OF ADDITIONAL INFORMATION. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED BY THE MANUFACTURING SITE ON (B)(4). PRODUCT CODE 121887654, WORK ORDER 8703337 WAS MANUFACTURED ON 29/DEC/17. 20 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WERE NO NCS OR DEVIATIONS ASSOCIATED WITH THIS LOT. COFC REVIEW: CERTIFICATE OF CONFORMITY REVIEW FOR 7203208, PRODUCT CODE 121887654, WORK ORDER 8703337 WAS COMPLETED AND MET SPECIFICATION.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). 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. H10 ADDITIONAL NARRATIVE: ADDED: A1, A2 AND A3. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4). 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. 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

    MEDICAL RECORDS RECEIVED. THE PATIENT REPORTS PAIN, WEAKNESS, REDUCED ENDURANCE, DECREASED RANGE OF MOTION AFTER THE PRIMARY SURGERY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN DEVICE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. (B)(4) USED TO CAPTURE THE SURGICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    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. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CERAMIC LINER WAS FRACTURED APPROXIMATELY 1 YEAR AFTER SURGERY. DOI: 1 YEAR AGO, DOR: UNKNOWN, UNKNOWN HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267160 CERAMAX CERAMIC INSERT 36 X 54 PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS MRA DEPUY ORTHOPAEDICS, INC. 1818910 8703337
    267167 CERAMAX CERAMIC INSERT 36 X 54 PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS MRA DEPUY ORTHOPAEDICS, INC. 1818910 8703337

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention