BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 NEUT 32IDX48OD

    MDR report key: 2113255 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-08855
    Event Type
    Injury
    Date Received
    May 20, 2011
    Report Date
    November 16, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K033273
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED AND ARE PRESUMED YET IMPLANTED. 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. 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

    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

    UPDATE: (B)(6) 2011 - MAUDE REPORT ((B)(4)) WAS RECEIVED, WHICH IDENTIFIED PART/LOT. THE POLY INSERT AND HEAD HAVE BEEN ADDED. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO MANUFACTURING DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR BOTH OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. MEDICAL RECORDS WERE REVIEWED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION MADE AVAILABLE. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(6) 2011 - MAUDE REPORT ((B)(4)) WAS RECEIVED, WHICH IDENTIFIED PART/LOT. THE METAL INSERT AND HEAD HAVE BEEN ADDED. MAUDE REPORT STATES (SUMMARIZED): FOR THE FIRST FEW MONTHS AFTER SURGERY, SHE WAS UNABLE TO LAY FLAT IN BED DUE TO THE PAIN. SHE ALSO EXPERIENCED A LOT OF DISCOMFORT, GRINDING, AND POPPING. HER DOCTOR STATED THAT IT WAS FROM THE LIGAMENTS AND TENDONS MOVING AROUND, AS WELL AS SCAR TISSUE, AND THAT THE X-RAYS ARE NORMAL. SHE ALSO HAS A BURNING SENSATION STARTING AT THE HIP INCISION AND RUNNING ALONG HER THIGH TO HER KNEE. HER SURGEON CLAIMS THIS IS BURSITIS. SHE HAS AN ACHING SENSATION IN HER GROIN WHEN TRANSITIONING FROM THE SITTING POSITION TO STANDING, AND IT IS STILL PAINFUL TO LAY DIRECTLY ON HER SIDE. WHILE SITTING, SHE CLAIMS IT FEELS LIKE SHE HAS SHOVED A ROCK UNDER HER HIP. SHE HAS A LUMP AT THE INCISION AREA, WHICH DOCTOR STATES IS NORMAL. NO MENTION OF REVISION SURGERY.

    Description of Event or Problem · 1

    UPDATE REC'D 11/16/2012- PFS AND MEDICAL RECORDS RECEIVED. 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

    LITIGATION PAPERS ALLEGE THAT ON OR ABOUT (B)(6) 2010, PT WAS IMPLANTED WITH A DEPUY PINNACLE ACETABULAR HIP ON HER RIGHT SIDE. SINCE HER SURGERY, PT HAS EXPERIENCED PAIN AND RESTRICTED MOBILITY. ADDITIONALLY, IT IS ALLEGED THAT PT WILL NEED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN MAR +4 NEUT 32IDX48OD POLY LINER LPH DEPUY ORTHOPAEDICS INC US NA D16H51000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention