BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +0

    MDR report key: 3355821 · Received September 18, 2013

    Report

    Report Number
    1818910-2013-27787
    Event Type
    Injury
    Date Received
    September 18, 2013
    Date of Event
    October 21, 2011
    Report Date
    October 18, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K120599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODE 2105328. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 2092284 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. 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. 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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- LITIGATION PAPERS ALLEGE PATIENT CONTINUES TO SUFFER WITH PAIN IN HER BACK AND LEGS, DIFFICULTY WALKING, SWELLING, AND A PULLING SENSATION IN HER RIGHT HIP AREA. DOI: (B)(6) 2006 - DOR: NONE REPORTED (RIGHT SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE: (B)(4) 2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED BY INVOICE SEARCH. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Description of Event or Problem · 1

    UPDATE MAY 31, 2017: LEGAL MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES PATIENT EXPERIENCED CRACKING IN HIP, LIMITATION ON DAILY ACTIVITIES, LEG LENGTH DISCREPANCY AND UNEVEN GAIT. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS FAILED TOTAL HIP ARTHROPLASTY DUE TO PAIN. ON THE CLINIC VISIT REPORT, IT WAS MENTIONED THAT THE PATIENT HAS HAD INCREASED PAIN, CLICKING AND ONE EPISODE OF RIGHT HIP SWELLING WITH PALPABLE ANTERIOR HIP MASS WITHIN THE PAST YEAR. PATIENTS OLD X-RAYS SHOWS A TOTAL HIP REPLACEMENT WITH A CALCAR REPLACEMENT WITH EVIDENCE OF LOOSENING OF THE FEMORAL COMPONENT AND CALCAR REABSORPTION. ON THE OPERATIVE NOTES, PATIENT HAD ABUNDANTLY THICKENED CAPSULE WITH SOME METALLOSIS ON THE INNER WALLS ON THE CAPSULE. THERE WAS SOME METALLOSIS SEEN ON THE BACKSIDE OF THE BEARING METAL. THERE WAS A SMALL PIECE OF BLACK CYSTIC AREA ON THE SUPERIOR PORTION OF THE ACETABULUM. ON (B)(6) 2016 OV NOTES STATED THAT THE CUP IS MALPOSITIONED HOWEVER THIS WAS NOT STATED IN THE REVISION. UPDATED THE PRODUCTS. THERE ARE NO LABORATORY VALUES PROVIDED. THIS COMPLAINT WAS UPDATED ON: JUN 8, 2017.

    Description of Event or Problem · 1

    UPDATE MAY 31, 2017: LEGAL MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES PATIENT EXPERIENCED CRACKING IN HIP, LIMITATION ON DAILY ACTIVITIES, LEG LENGTH DISCREPANCY AND UNEVEN GAIT. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS FAILED TOTAL HIP ARTHROPLASTY DUE TO PAIN. ON THE CLINIC VISIT REPORT, IT WAS MENTIONED THAT THE PATIENT HAS HAD INCREASED PAIN, CLICKING AND ONE EPISODE OF RIGHT HIP SWELLING WITH PALPABLE ANTERIOR HIP MASS WITHIN THE PAST YEAR. PATIENTS OLD X-RAYS SHOWS A TOTAL HIP REPLACEMENT WITH A CALCAR REPLACEMENT WITH EVIDENCE OF LOOSENING OF THE FEMORAL COMPONENT AND CALCAR REABSORPTION. ON THE OPERATIVE NOTES, PATIENT HAD ABUNDANTLY THICKENED CAPSULE WITH SOME METALLOSIS ON THE INNER WALLS ON THE CAPSULE. THERE WAS SOME METALLOSIS SEEN ON THE BACKSIDE OF THE BEARING METAL. THERE WAS A SMALL PIECE OF BLACK CYSTIC AREA ON THE SUPERIOR PORTION OF THE ACETABULUM. THE (B)(6) 2016 OV NOTES STATED THAT THE CUP IS MALPOSITIONED HOWEVER THIS WAS NOT STATED IN THE REVISION. OFFICE VISIT NOTES ON (B)(6) 2016 REPORTED THAT THE PATIENT WAS EXPERIENCING TROCHANTERIC BURSITIS AS A COMPLICATION OF THE REVISION AND THAT THE PATIENT HAD SURGERY FOR TROCHANTERIC BURSECTOMY AND IRRIGATION & DEBRIDEMENT. UPDATED THE PRODUCTS. THERE ARE NO LABORATORY VALUES PROVIDED. THIS COMPLAINT WAS UPDATED ON: JUN 8, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469639 S-ROM M HEAD 36MM +0 FEMORAL HEAD KWA DEPUY ORTHOPAEDICS INC US 2092284

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other