BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ACETABULAR LINER

    MDR report key: 3172925 · Received June 17, 2013

    Report

    Report Number
    1818910-2013-19044
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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. PATIENT WAS REVISED TO ADDRESS POLY WEAR AND GROIN PAIN. DOI UNK - DOR (B)(6) 2013 (RIGHT HIP). UPDATE 07/09/2013 - MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION THE LINER SHOWED EVIDENCE OF PISTONING WITH ECCENTRIC WEAR. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. (B)(6). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. MEDICAL RECORDS DATED (B)(6) 2013 STATE THE PATIENT IS A MALE, 70 INCHES TALL, (B)(6), WITH A CALCULATED BMI OF 43. THE PATIENT IS CONSIDERED OBESE. IT IS STATED IN THE WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT TENDS TO ADVERSELY AFFECT HIP REPLACEMENT IMPLANTS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE. MEDICAL RECORDS WERE OBTAINED. THE DEPUY LEGAL NURSE STATED WITH THE LENGTH OF TIME BETWEEN INITIAL IMPLANT AND DATE OF REVISION, IT WOULD NOT BE UNEXPECTED TO OBSERVE SOME POLY WEAR. ALTHOUGH UNLIKELY IT CANNOT BE DETERMINED, BASED ON THE INFORMATION AVAILABLE, THAT THE COMPLAINT IS PRODUCT RELATED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS POLY WEAR AND GROIN PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274378 UNKNOWN DEPUY ACETABULAR LINER ACETABULAR LINER LPH 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention