BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 44MM +5.0

    MDR report key: 3061862 · Received April 16, 2013

    Report

    Report Number
    1818910-2013-15448
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    April 5, 2013
    Report Date
    December 2, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    PMA / PMN Number
    PK073570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. 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 THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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. 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.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.(B)(4).

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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

    PATIENT WAS REVISED TO ADDRESS INFECTION.

    Description of Event or Problem · 1

    UPDATE 12/24/15- PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PFS REPORTED PAIN. MEDICAL RECORDS REPORTED THE PATIENT WITH WOUND/INCISION DRAINAGE, SUBCUTANEOUS PURULENT TISSUE, DEFECT IN FASCIA LATA WITH A HEMATOMA AND PURULENT FLUID, COPIOUS PURULENT FLUID IN THE HIP JOINT, NECROTIC AND NONVIABLE TISSUE DEBRIDEMENT. JOINT EFFUSION WAS ASPIRATED. FLUID, WOUND AND TISSUE CULTURES POSITIVE FOR (B)(6) INFECTION. IT ALSO REPORTED THE PATIENT TO HAVE GAIT DIFFICULTY. SCREWS, CUP, AND STEM ADDED TO COMPLAINT AND REPORTED RELATED TO INFECTION BEING LESS THAN 3 MONTHS AFTER SURGERY. THE COMPLAINT WAS UPDATED ON: JAN 15, 2016.

    Description of Event or Problem · 1

    UPDATE REC'D 9/17/2014 - PFS AND MEDICAL RECORDS RECEIVED. LOT PROVIDED FOR THE FEMORAL HEAD. AFTER REVIEW OF THE MEDICAL RECORDS THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    UPDATE12/02/16 ¿ PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVSTIGATION.

    Description of Event or Problem · 1

    PLAINTIFF FACT SHEET, STICKER SHEETS AND MEDICAL RECORDS RECEIVED. THE PFS ALLEGES THAT THE PATIENT HAD PSEUDOTUMORS AND ELEVATED METAL IONS AFTER THE FIRST REVISION. HOWEVER, THE LINER WAS POLYETHYLENE AND THE HEAD WAS CERAMIC. PREVIOUS LAB RESULTS INDICATED THAT THE VALUES WERE BELOW 7PPB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162062 DLT TS CER HD 12/14 44MM +5.0 FEMORAL HEAD LZO DEPUY ORTHOPAEDICS INC US 3544209

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention