BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPHERE M SPEC 11/13 36 +0

    MDR report key: 2851120 · Received November 29, 2012

    Report

    Report Number
    1818910-2012-22958
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    September 3, 2014
    Report Date
    October 22, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK120599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE INVESTIGATION IS ONGOING. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS 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. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4) - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED, WHICH INDICATED THAT THE PATIENT WAS IMPLANTED WITH POLY. THE ORIGINAL ALLEGATION WAS ONLY PAIN; THEREFORE, WE ARE ADDING AND REPORTING ALL PRODUCTS. ADDITIONALLY, OPERATIVE NOTES INDICATED A CYST AND CUP LOOSENING. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 127218, 171111, C445260, 573194 . THE LOT CODE WAS NOT PROVIDED FOR ONE OF THE PINNACLE BONE SCREWS. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 3106324 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, THE COMPLAINT IS UNLIKELY TO BE PRODUCT RELATED. 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. 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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FOR THE PROVIDED PRODUCT AND LOT COMBINATIONS DID NOT FIND ANY OTHER COMPLAINTS AGAINST THEM. THE LOT CODES 127218 AND 3106324 THAT WERE MENTIONED IN THE INITIAL INVESTIGATION WERE REPORTED IN ERROR. THESE TWO LOT CODES ARE NOT ASSOCIATED WITH THIS COMPLAINT. A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE STEM ASSOCIATED WITH THIS COMPLAINT AS THE PRODUCT AND LOT CODE WAS NOT PROVIDED. 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. 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

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN.

    Description of Event or Problem · 1

    UPDATE 1/5/2016- PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PFS REPORTED PAIN, DISCOMFORT WITH WALKING, STANDING AND SITTING AND LIMITED DAILY ACTIVITIES BECAUSE OF CANE USE WITH WALKING. MEDICAL RECORDS REPORTED A RESOLVED LARGE CYST, MILD HETEROTOPIC OSSIFICATION ADJACENT TO THE GREATER TROCHANTER, FLUID COLLECTION AND BURSITIS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: JAN 28, 2016.

    Description of Event or Problem · 1

    UPDATE REC'D 10/22/2014- PFS AND MEDICAL RECORDS RECEIVED. A CORRECT DOI AND DOR WERE PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN. THERE WAS NO MENTION OF CUP LOOSENING OR A CYST. THE PART/LOT NUMBERS WERE BEING UPDATED FOR THE LINER, FEMORAL HEAD, AND FIRST SCREW. A UNKNOWN DEPUY STEM IS BEING ADDED TO THE COM AS IT ALSO CANNOT BE EXCLUDED AS THE CAUSE OF PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPHERE M SPEC 11/13 36 +0 HIP FEMORAL HEAD LPH DEPUY ORTHOPAEDICS INC US 3480050

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R