BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXLE LARGE

    MDR report key: 17841961 · Received September 29, 2023

    Report

    Report Number
    3008021110-2023-00108
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    August 8, 2023
    Report Date
    September 28, 2023
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    JDB
    PMA / PMN Number
    K222807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #'S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE DEVICE. THEREFORE, THE PRODUCT WITH THESE LOT#'S HAS BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THE DEVICE INVOLVED WAS NOT EXPLANTED SO IT COULD NOT BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE PREVIOUS SURGERY WERE REQUESTED BUT NOT AVAILABLE. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT. · THE CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENT MANUFACTURED WITH THE INVOLVED LOT#, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. · THE PATIENT'S MEDICAL RECORDS SHOW A HISTORY OF SEVERAL REVISION / DEBRIDEMENT, AND NOTATIONS FOR CHRONIC INFECTION. SEROMA BUILD-UP OVER THE LEFT ELBOW WAS DRAINED, AND SEROUS ASPIRATE WAS OBTAINED AND CULTURED. ONCE RESULTS WERE RETURNED, THE ASPIRATION WAS CONSISTENT WITH A STAPH INFECTION. WE CAN SUPPOSE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA THE EVENT REPORTED BY COMPLAINT SOURCE IS INFECTION OF A CUSTOMIZED HUMERAL IMPLANT. NO REVISION RATE IS TO BE PROVIDED SINCE CUSTOMIZED IMPLANTS ARE MANUFACTURED AS SINGLE PIECES. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND THAT THIS IS A CUSTOM-MADE DEVICE, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUES. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION WITH A TOTAL ELBOW ARTHROPLASTY WITH COMPASSIONATE USE OF A PATIENT-MATCHED ELBOW REPLACEMENT IMPLANT. ON FIRST POSTOPERATIVE FOLLOW-UP, X-RAYS TAKEN OF THE LEFT ELBOW REVEALED A CLINICALLY STABLE LINKED TOTAL ELBOW ARTHROPLASTY. UNFORTUNATELY, PATIENT LATER DEVELOPED AN ACUTE PERIPROSTHETIC JOINT INFECTION AND WAS SEEN ON (B)(6) 2023 FOR FURTHER EVALUATION. AT THAT TIME, SEROMA BUILD-UP OVER THE LEFT ELBOW WAS DRAINED, AND SEROUS ASPIRATE WAS OBTAINED AND CULTURED. ONCE RESULTS WERE RETURNED, THE ASPIRATION WAS CONSISTENT WITH A STAPH INFECTION. HENCE, THE PATIENT WAS OPERATED ON (B)(6) 2023 EMERGENTLY. (NO REVISION) AFTER SURGERY, ON (B)(6) 2023, HE WAS EVALUATED BY THE INFECTIOUS DISEASE TEAM AND HAD A PICC LINE PUT IN PLACE. ON HIS SECOND EVALUATION, ON (B)(6) 2023, THE PATIENT WAS CLINICALLY STABLE AND HAS BEEN COMPLIANT WITH HIS IV ANTIBIOTICS REGIMENT AS PLANNED. AS OF HIS LATEST EVALUATION, ON (B)(6) 2023, HE DENIES NOTICING ANY DRAINAGE, FEVERS, AND CHILLS. HIS PHYSICAL EVALUATION REVEALED IMPROVEMENT IN ELBOW FLEXION STRENGTH. CURRENTLY, THE PATIENT IS STILL BEING SEEN AND TREATED BY AN INFECTIOUS DISEASE TEAM AND HAD A FOLLOW-UP APPOINTMENT SCHEDULED FOR ON (B)(6) 2023. THE PATIENT WILL BE SEEN IN THE CLINIC ON (B)(6) 2023 WITH NEW LEFT ELBOW X-RAYS FOR REVIEW. HE WILL CONTINUE WITH LIFETIME LIFTING RESTRICTIONS OF 10 POUNDS AND REPETITIVE LIFTING 2 POUNDS WITH THE LEFT UPPER EXTREMITY. IF THE PATIENT STAYS INFECTION FREE THERE WILL BE NO REVISION. COMPONENTS SUSPECTED, HUMERAL BODY LARGE LEFT+SCREW, COMMERCIAL CODE 155.015.120 - LOT#: 2100718 - STER#: 2300054. ULNAR BODY LARGE LEFT + SCREW, COMMERCIAL CODE 1552.14.020 - LOT#: 2314239 - STER#: 2300145. ULNAR LINER - LARGE LEFT TEMA COMMERCIAL CODE 1560.50.020 - LOT#: V18AT1Q3 - STER#: 2000044. AXLE #LARGE COMMERCIAL CODE 1590.150.20 - LOT#: 2227696 - STER#: 2300054. CMD 23-1130 HUMERAL IMPLANT, COMMERCIAL CODE 9618.15.08Z - LOT#: 2315491 - STER#: 2300138. CMD 23-1130 ULNAR IMPLANT, COMMERCIAL CODE 9618.15.090 - LOT#: 2315490 - STER#: 2300138. PATIENT - MALE. DATE OF BIRTH: ON (B)(6) 1951. EVENT HAPPENED IN U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352876 AXLE LARGE AXLE LARGE JDB LIMACORPORATE S.P.A 1590.15.020 2227696

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other