BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL TIBIAL METS

    MDR report key: 5004443 · Received August 12, 2015

    Report

    Report Number
    3004105610-2015-00074
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K121029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED COMPLICATIONS. PRODUCT FROM THE SAME BATCH WAS REVIEWED ALONG WITH PARTS FROM OTHER BATCHES AND THE ISSUE CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED IN NOVEMBER 2016, STANMORE IMPLANTS WORLDWIDE INITIATED A FIELD SAFETY CORRECTIVE ACTION THAT INCLUDED THE USA ON THE ORIENTATION OF DEVICES DURING DISTRIBUTION REFERENCE STANMORE # (B)(4). FUTURE REMITTANCE OF INFORMATION WILL BE DONE THROUGH THE FSCA. CORRECTIONS: BRAND NAME CORRECTED FROM METS MODULAR DISTAL FEMUR IMPLANT TO PROXIMAL TIBIAL METS.

    Additional Manufacturer Narrative · 1

    THE TWO ADD'L TIBIAL COMPONENTS (BATCHES A9990 & A11290) THAT WERE OPENED DURING THE PROCEDURE WERE RETURNED TO SIW, ALONG W/THEIR POUCHES & PACKAGING. UPON INSPECTION OF THESE DEVICES, IT WAS OBSERVED THAT THE END OF THE TIBIAL COMPONENTS HAD PENETRATED THE POUCH. SIW HAD THE POUCHES EXAMINED BY AN EXTERNAL PACKAGING COMPANY, WHO CONCLUDED THA THE FAILURE WAS DUE TO AN EXCESSIVE IMPACT RATHER THAN FATIGUE, OR WEAR & TEAR. SHELF STOCK FROM BATCH A11290 WAS AVAILABLE AND INSPECTED. THERE WAS NO REMAINING STOCK FOR BATCHES A7186 OR A9990. THE PACKAGING AND POUCHES FOR THE REMAINING SHELF STOCK, BATCH A11290, WERE CONFIRMED TO BE INTACT. IN AN ATTEMPT TO RECREATE THE FAILURE, A DROP TEST WAS PERFORMED AT 770MM, AS PER ISTA STANDARDS, W/OTHER TIBIAL COMPONENTS THAT ARE PACKAGED IN THE SAME STANDARD PACKAGING. ON REVIEWING THE SAMPLES, THERE WAS SOME EVIDENCE OF SCRATCHING, BUT NO BREACHES OF THE PACKAGING. POUCH INTEGRITY TESTING CONFIRMED THERE WERE NO LEAKS. SIW IS CONTINUING ITS' INVESTIGATION. A SUPPLEMENTAL REPORT W/BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING FOR A TIBIAL COMPONENT (BATCH A7186) HAD BEEN DAMAGED. THE TIBIAL STEM WAS REPORTED TO HAVE PERFORATED THE STERILE PACKAGING. THE OUTER BOXES, SHRINK WRAP AND ALL SEALS WERE REPORTED TO BE INTACT. THE SURGEON OPENED 2 ADDITIONAL TIBIAL COMPONENTS(BATCHES A9990 & A11290) AS REPLACEMENTS, AND NOTED SIMILAR DAMAGED POUCHES. IN ORDER TO COMPLETE THE PROCEDURE THE ORIGINAL TIBIAL COMPONENT (BATCH A7186) WAS FLASH-STERILIZED AND IMPLANTED. THIS LED TO A DELAY OF SURGERY OF ONE HOUR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. BATCH # A7186 IS THE SUBJECT OF THIS REPORT. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2015-00074 ((B)(4)) BATCH # A9990SIW IS THE SUBJECT OF (B)(4): MFR REPORT # 3004105610-2015-00076. BATCH # A11290 IS THE SUBJECT OF (B)(4): MFR REPORT # 3004105610-2015-00077.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING FOR A TIBIAL COMPONENT (BATCH A7186) HAD BEEN DAMAGED. THE TIBIAL STEM WAS REPORTED TO HAVE PERFORATED THE STERILE PACKAGING. THE OUTER BOXES, SHRINK WRAP AND ALL SEALS WERE REPORTED TO BE INTACT. THE SURGEON OPENED 2 ADD'L TIBIAL COMPONENTS (BATCHES A9990 & A11290) AS REPLACEMENTS, AND NOTED SIMILAR DAMAGED POUCHES. IN ORDER TO COMPLETE THE PROCEDURE THE ORIGINAL TIBIAL COMPONENT (BATCH A7186) WAS FLASH-STERILIZED AND IMPLANTED. THIS LED TO A DELAY OF SURGERY OF ONE HOUR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. REFER TO MDR#3004105610-2015-00076 & MDR #3004105610-2015-00077. PLS NOTE THAT MDR#3004105610-2015-00076 & MDR #3004105610-2015-00077 ARE ASSOCIATED W/ONE SURGICAL EVENT, WHEREBY MULTIPLE DEVICES IN THE HOSPITAL'S STOCK WERE NOTED TO HAVE DAMAGED PACKAGING. IN TOTAL, THREE DEVICES WERE INVOLVED, THUS THREE MDRS HAVE BEEN FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529793 PROXIMAL TIBIAL METS LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD MKRHM/SMST A7186

    Patients

    Seq Age Sex Outcome Treatment
    1