BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 40MM +8.5

    MDR report key: 2071320 · Received April 13, 2011

    Report

    Report Number
    1818910-2011-06238
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    July 22, 2010
    Report Date
    March 14, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    LZO
    PMA / PMN Number
    K071830
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    PPF ALLEGES DISLOCATION, INFECTIONS, ELEVATED METAL IONS AND PULMONARY EMBOLISM.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: AFTER THE REVISION SURGERY, PT WAS IN EXCRUCIATING PAIN; PT'S HIP IMPLANT DISLOCATED WHILE HE WAS SITTING AT THE DINNER TABLE; PT'S HIP HAD ACCUMULATED MORE "CREAMY RUST COLORED FLUID" THAT HAD TO BE EXTRACTED FROM HIS HIP ON SEVERAL OCCASIONS; PT'S HIP DISLOCATED AGAIN AND HE UNDERWENT AN EMERGENCY PROCEDURE UNDER CONSCIOUS SEDATION TO REDUCE HIS HIP BACK INTO THE JOINT; DR NOTED THAT PT'S HIP HAD A GREENISH, NECROTIC TISSUE ALL AROUND THE AREA OF THE ACETABULUM AND HIP PROSTHESIS PROXIMALLY; MOST OF THE CAPSULAR STRUCTURES WERE COMPLETELY NECROTIC AND THE #5 ETHIBOND SUTURES USED TO ANCHOR THE ANTERIOR CAPSULE BACK HAD RIPPED OUT OF THIS NECROTIC CHEESY TISSUE; PT HAD ELEVATED LEVELS OF COBALT IN HIS BLOOD; DURING SECOND REVISION SURGERY, DR FOUND SOFT TISSUE WAS "VERY WOODY AND HARD" AND THEY HAD ENCOUNTERED A CONSIDERABLE AMOUNT OF "AVASCULAR YELLOWISH SOLID-LOOKING TISSUE THAT HAD REPLACED ALL OF THE PT'S ABDUCTORS, BOTH THE GLUTEUS AND MEDIUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DLT TS CER HD 12/14 40MM +8.5 87LZO LZO DEPUY INTERNATIONAL, LTD. NA 3044013

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention