BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX NEUT 32IDX52OD

    MDR report key: 9369786 · Received November 25, 2019

    Report

    Report Number
    1818910-2019-117830
    Event Type
    Injury
    Date Received
    November 25, 2019
    Date of Event
    December 21, 2018
    Report Date
    October 30, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    K062148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. 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. ADDENDUM ADDED (B)(6)2020. 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. DEVICE HISTORY LOT: DHR REVIEW: PRODUCT CODE 121881752, WORK ORDER 8062917 WAS MANUFACTURED ON 09/FEB/15. 20 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WERE NO NCS OR DEVIATIONS ASSOCIATED WITH THIS LOT. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 0

    PATHOLOGY REPORT (B)(6) 2018 INDICATES RECEIPT OF CONNECTIVE TISSUE SPECIMENS FROM INTRA-OPERATIVE COLLECTION. FINDINGS INCLUDE SCARRED SOFT TISSUE WITH REACTIVE BONE AND CARTILAGE CHANGES. SLIGHT CHRONIC SYNOVITIS, INFLAMMATION, AND FLORID PURULENT DISCHARGE. IT IS INDICATED THAT THE PATIENT WAS DIAGNOSED BETWEEN (B)(6) 2018 AND FROM (B)(6) 2018 - (B)(6) 2019, WITH CHRONIC RENAL FAILURE AND NSTEMI. THE PATIENT HAS A COMPLEX MEDICAL HISTORY WITH MULTISYSTEM INVOLVEMENT. THERE IS NO INDICATION THAT DEPUY PRODUCT CAUSED OR CONTRIBUTED TO THE PATIENTS DIAGNOSIS OF CHRONIC RENAL FAILURE AND / OR NSTEMI.

    Additional Manufacturer Narrative · 1

    (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

    MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT HAD UNDERGONE AN IRRIGATION AND DEBRIDEMENT ON (B)(6) 2018 TO ADDRESS INFECTION. HEAD AND LINER WERE REVISED AND AN UNSPECIFIED RESORBABLE ANTIBIOTIC CARRIER WAS PLACED. NO PART/LOT CODES AVAILABLE FOR THE IMPLANTED LINER AND HEAD, BUT THESE WERE IDENTIFIED TO BE A DEPUY PINNACLE POLYETHYLENE INLAY NEUTRAL 52/32 MM AND A BIOLOX CERAMIC REVISION HEAD, DIAMETER 32 MM + 1 MM. THE PATIENT HAD POSTOPERATIVE ANEMIA AND SO WAS TRANSFUSED WITH 7 UNITS PACKED RED BLOOD CELLS. ON (B)(6) 2018, THE PATIENT HAD UNDERGONE AN IRRIGATION AND DEBRIDEMENT FOR POST-OPERATIVE REDNESS OF THE RIGHT HIP WOUND WITH EVIDENCE OF INFECTION. NO IMPLANTS WERE REVISED AT THIS TIME. ON (B)(6) 2019, THE PATIENT HAD UNDERGONE A THIRD IRRIGATION AND DEBRIDEMENT TO ADDRESS INFLAMMATION, INFECTION, TO EVACUATE A HEMATOMA AND TO ADDRESS RUPTURE OF FASCIA AFTER CHANGE OF THE RUPTURED CERAMIC PARTS OF A CEMENTLESS TEP. THE TISSUE WAS INFECTED, THERE WAS DEHISCENCE OF THE FASCIA AND NECROSIS. NO PRODUCTS WERE REVISED. DOI: (B)(6) 2018; DOR: (B)(6) 2018 (RIGHT HIP). CUP WAS PREVIOUSLY REPORTED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163848 ALTRX NEUT 32IDX52OD JRN : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS, INC. 1818910 J00J33

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention