BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP PROXIMAL LATERAL TIBIA PLATE 7 HOLES/180MM-RIGHT

    MDR report key: 4513185 · Received February 12, 2015

    Report

    Report Number
    2520274-2015-10930
    Event Type
    Injury
    Date Received
    February 12, 2015
    Report Date
    January 30, 2015
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HRS
    PMA / PMN Number
    PK052390
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    A MANUFACTURING EVALUATION WAS COMPLETED: ALL SCREWS ARE MADE OF STAINLESS STEEL. THE EXAMINATION OF THE RAW-MATERIAL INSPECTION SHEET OF THE SUPPLIER AND THE MANUFACTURING DOCUMENTS OF THE PRODUCER SHOWED NO DEVIATION IN RELATION TO THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES. THE MATERIAL OF ALL OF THE SCREWS IS IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS. THE DIMENSIONS OF THE INVESTIGATED SCREWS (AS FAR AS MEASURABLE) WERE CHECKED USING A DIGITAL SLIDING CALIPER AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING OF THE PRODUCER AND AO/ASIF SPECIFICATIONS; TWO SCREWS ARE NOT IN ACCORDANCE TO THE TECHNICAL DRAWING OF THE PRODUCER. CORROSION MARKS (BROWN FILM/COAT) WERE OBSERVED IN SEVERAL PLATE HOLES OF THE RECEIVED LOCKING COMPRESSION PLATE AND ON SIX OF THE 9 SCREW HEADS. THE CORROSION ON THE CORTEX SCREWS RESULTS FROM MICROMOVEMENTS BETWEEN THE SCREW HEAD AND THE PLATE. THE MICROMOVEMENTS CAUSE DAMAGE TO THE PASSIVATION LAYER OF THE METAL AND PANDER CREVICE CORROSION OR PITTING CORROSION. THE DEVICES WERE EXAMINED AT THE BROWN AREAS (FILM/COAT) AND NEARBY USING THE SCANNING ELECTRON MICROSCOPE (SEM) AND QUALITATIVE ENERGY DISPERSIVE X-RAY ANALYSIS (EDX). THE BROWN AREAS ARE MAINLY LOCATED ON THE SCREW HEADS. THE SEM IMAGES SHOWED A FEW AREAS WITH PITTING ON THE SCREW HEADS. WHEN USING THE EDX ANALYSIS SEVERAL ORGANICALLY RESIDUES (HUMAN RESIDUES AND CORROSION PRODUCTS) WERE FOUND. THE DETECTED IRON AND OXYGEN ARE AN INDICATION OF CORROSION PRODUCTS (RUST). THIS SECONDARY CORROSION IS A RESULT OF A SLIGHT CREVICE SITUATION BETWEEN THE SCREW HEADS AND THE PLATE HOLES IN COMBINATION WITH MICROMOVEMENTS. THE PROCESS AFFECTS PASSIVATION LAYER OF THE METAL AND PANDERS CORROSION. SEM OBSERVATIONS AND FINDINGS SHOWED NO ABNORMALITIES. BASED ON THE RESULTS OF THE QUALITATIVE ENERGY DISPERSIVE X-RAY ANALYSIS WE CAN CONCLUDE THAT MOST OF THE BROWN AREAS ARE RUST AND HUMAN RESIDUES. FOR METALLIC IMPLANTS, ESPECIALLY OF IMPLANTS MADE OF STAINLESS STEEL IT SHOULD BE NOTED THAT SEVERAL MECHANISMS CAN LEAD TO CORROSION IN THE AQUEOUS ENVIRONMENTS OF BODY FLUIDS. A FAILURE RESULTING FROM EITHER MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: 1X (ONE) LOCKING COMPRESSION PLATE PROXIMAL LATERAL TIBIAL PLATE (LCP-PLT) WITH CORROSION MARKS, ART.NO.222.222, LOT 7882218. OUR INVESTIGATION SHOWS THAT THERE ARE SPOTTY RED AREAS VISIBLE ON THE PLATE AND SCREWS. THE MANUFACTURING REVIEW, OF ALL ABOVE MENTIONED ARTICLES, SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. WE HAVE FORWARDED THE COMPLAINT TO THE RMS FOUNDATION FOR A FURTHER INVESTIGATION WITH THE FOLLOWING RESULTS: THE RECEIVED DEVICES WERE IMPLANTED ON (B)(6) 2013. ACCORDING TO THE DEVICE REPORT THE RETRIEVAL OF THE DEVICES WAS PLANNED AND PERFORMED ON (B)(6) 2014. THEREBY THE SURGEON FOUND SEVERAL LOCATIONS WITH TRACES OF CORROSION (RUST). THE CORRODED DEVICES ARE SUSPECTED TO CAUSE AN INFLAMMATORY REACTION TO THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO REPORT WITH RESPECT TO THE AFTERCARE OF THE PATIENT. NO PRODUCT FAULT COULD BE DETECTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT REMOVAL OF THE DEVICE ON (B)(6) 2014, THE SURGEON NOTICED TRACES OF EROSION (RUST) AT SEVERAL LOCATIONS ON THE DEVICE HAVING ENTRAINED INFLAMMATION AT THE PATIENT. THE DEVICE WAS IMPLANTED ON (B)(6) 2013; THE REMOVAL OF THE IMPLANT WAS PROGRAMMED. THE DEVICE WAS RUSTED CAUSING AN INFLAMMATORY REACTION. UNKNOWN IF THERE IS ANY PATIENT IMPACT EXCEPT AN INFLAMMATORY REACTION TO THE RUST. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106671 LCP PROXIMAL LATERAL TIBIA PLATE 7 HOLES/180MM-RIGHT PLATE,FIXATION,BONE HRS SYNTHES GRENCHEN 7882218

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention