BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX HOLE ELIM POSITIVE STOP

    MDR report key: 10442820 · Received August 24, 2020

    Report

    Report Number
    1818910-2020-18592
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Date of Event
    August 11, 2020
    Report Date
    August 11, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295019688
    PMA / PMN Number
    K963309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H6 PATIENT CODE: NO CODE AVAILABLE (3191) USED TO CAPTURE THE INSUFFICIENT INFORMATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). INVESTIGATION SUMMARY ==> EXAMINATION OF THE RETURNED DEVICE FINDS NOTHING OUTWARD TO SUGGEST A PRODUCT PROBLEM. AS PART OF A LARGER INVESTIGATION IT UNDERSTOOD THE HOLE ELIMINATOR WAS NOT THE CONTRIBUTING FACTOR IN THIS ISSUE. A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM DID IDENTIFY NC NR-0142894 ASSOCIATED WITH THIS PRODUCT/LOT COMBINATION. THE NON-CONFORMANCE WAS PACKAGING/LABELING RELATED AND NOT AT ALL ASSOCIATED WITH MANUFACTURING, MATERIAL OR DIMENSIONAL INSPECTION. THERE IS NO EVIDENCE THE NON-CONFORMANCE REPORT (NR) HAS ANY BEARING ON THIS ALLEGATION OR INVESTIGATIVE RESULTS. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT ==> LOT D20032399. A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM DID IDENTIFY NC NR-0142894 ASSOCIATED WITH THIS PRODUCT/LOT COMBINATION. THE NON-CONFORMANCE WAS PACKAGING/LABELING RELATED AND NOT AT ALL ASSOCIATED WITH MANUFACTURING, MATERIAL OR DIMENSIONAL INSPECTION. DEVICE HISTORY REVIEW ==> A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM DID IDENTIFY NC NR-0142894 ASSOCIATED WITH THIS PRODUCT/LOT COMBINATION. THE NON-CONFORMANCE WAS PACKAGING/LABELING RELATED AND NOT AT ALL ASSOCIATED WITH MANUFACTURING, MATERIAL OR INSPECTION. CORRECTED H3

    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

    IT WAS REPORTED THAT THE APEX HOLE ELIMINATOR DID NOT HAVE A POSITIVE STOP. POSSIBLE DEFECTIVE 48MM SECTOR CUP. APEX HOLE ELIMINATOR WAS SCREWED ALL THE WAY THROUGH THE APEX HOLE OF THE CUP. SURGERY WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906074 APEX HOLE ELIM POSITIVE STOP PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT LPH DEPUY ORTHOPAEDICS INC US 1246-03-000 D20032399 10603295019688

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR