BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTL. REV. STEM Ø15 MM

    MDR report key: 8508903 · Received April 12, 2019

    Report

    Report Number
    3008021110-2019-00043
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    March 26, 2019
    Report Date
    March 12, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K113523
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF THE DHR: BY CHECKING THE MANUFACTURING CHARTS OF THE LOTS INVOLVED, NO ANOMALY WAS FOUND ON THE PRODUCTS PLACED ON THE MARKET, MEANING THAT THEY HAD NO PRE-EXISTING ANOMALY. FOCUSING ON THE STEM INVOLVED (SMR CEMENTLESS REVISION STEM Ø15 MM WITH CODE #1308.15.154, LOT #1600368), (B)(4) STEMS MANUFACTURED WITH THE SAME LOT# WERE IMPLANTED WITHOUT RECEIVING ADDITIONAL COMPLAINTS. EVEN BY CONSIDERING THE OTHER EXPLANTED COMPONENTS, THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE SAME LOTS. EXPLANTS ANALYSIS: EXPLANTS NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS (DISPOSED OFF AS PER HOSPITAL POLICY). X-RAYS ANALYSIS: X-RAYS NOT AVAILABLE FOR FURTHER ANALYSIS. BASED ON THE VERY FEW INFO RECEIVED, WE CAN CONCLUDE THAT THIS EVENT WAS LIKELY DUE TO POOR PATIENT CONDITION MAYBE COMBINED WITH SURGICAL FACTOR (AS PER SURGEON REMARKS REPORTED). EVENT NOT PRODUCT RELATED. PMS DATA: (B)(4). MOST OF THESE EVENTS REPORTED ARE RELATED TO PATIENT CONDITION OR SURGICAL FACTOR. ACCORDING TO THE COMPLAINTS INVESTIGATED, NONE OF THE EVENTS REPORTED WAS PRODUCT RELATED. NO SPECIFIC CORRECTIVE ACTION FOR THIS CASE. LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FUTURE SIMILAR ISSUE.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO SHOULDER DISLOCATION OCCURRED ON (B)(6) 2019. PRIMARY SURGERY OCCURRED ON (B)(6) 2019 AND WAS DUE TO PAIN AT THE PROXIMAL HUMERUS. IT WAS REPORTED THAT THE PATIENT HAD AN OLD PROXIMAL HUMERAL FRACTURE THAT WAS MANAGED CONSERVATIVELY AND ENDED UP WITH A TERRIBLE MALUNION. DUE TO PAIN, THE PATIENT REQUIRED A SHOULDER REPLACEMENT AND DUE TO THE DISTORTED PROXIMAL HUMERUS, SMR CEMENTLESS REVISION STEM Ø15 MM (CODE #1308.15.154, LOT #1600368) WAS IMPLANTED ON (B)(6) 2019 (PRIMARY SURGERY'S DATE). INITIALLY THE STEM WAS VERY STABLE BUT THEN HAD SOME SUBSIDENCE AND DISLOCATED. BESIDES THE STEM, SMR REVERSE FINNED HUMER. BODY (CODE #1352.15.050, LOT #1901330) AND SMR REVERSE HP LINER LONG (CODE #1362.09.020, LOT #1709122) HAVE BEEN REPLACED. THE SURGEON SAID THAT PROBABLY HE MANAGED TO SINK THE STEM FURTHER AT THE INITIAL SURGERY, EVEN THOUGH THE JOINT WAS TESTED AFTER WITHOUT SHOWING ISSUES. EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#S NO PRE - EXISTING ANOMALIES WERE FOUND. THIS IS THE FIRST AND ONLY COMPLAINT INVOLVING THESE LOT #S. WE WILL SUBMIT A FINAL REPORT ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO SHOULDER DISLOCATION OCCURRED ON (B)(6) 2019. PRIMARY SURGERY OCCURRED ON (B)(6) 2019 AND WAS DUE TO PAIN AT THE PROXIMAL HUMERUS. IT IS REPORTED THAT THE PATIENT HAD AN OLD PROXIMAL HUMERAL FRACTURE THAT WAS MANAGED CONSERVATIVELY AND ENDED UP WITH A TERRIBLE MALUNION. DUE TO PAIN, THE PATIENT REQUIRED A SHOULDER REPLACEMENT AND DUE TO THE DISTORTED PROXIMAL HUMERUS THE REVISION STEM SMR CEMENTL. REV. STEM Ø15 MM (CODE #1308.15.154, LOT #1600368) WAS IMPLANTED ON (B)(6) 2019. INITIALLY THE STEM WAS VERY STABLE BUT THEN HAD SOME SUBSIDENCE AND DISLOCATED. BESIDES THE STEM, SMR REVERSE FINNED HUMER. BODY (CODE #1352.15.050, LOT #1901330) AND SMR REVERSE HP LINER LONG (PRODUCT NOT MARKED IN USA) HAVE BEEN REPLACED. THE SURGEON SAID THAT PROBABLY HE MANAGED TO SINK THE STEM FURTHER AT THE INITIAL SURGERY EVEN THOUGH THE JOINT WAS TESTED AFTER. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301154 SMR CEMENTL. REV. STEM Ø15 MM SMR CEMENTL. REV. STEM Ø15 MM KWS LIMACORPORATE SPA 1308.15.154 1600368

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention