BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 5811974 · Received July 21, 2016

    Report

    Report Number
    2520274-2016-13565
    Event Type
    Injury
    Date Received
    July 21, 2016
    Date of Event
    August 11, 2009
    Report Date
    July 14, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN LOCKING COMPRESSION PLATE¿PROXIMAL LATERAL TIBIA (LCP PLT), UNKNOWN QUANTITY / UNKNOWN LOT. (OTHER NUMBER) UDI # UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: OH, J.K., ET AL. (2010). TECHNICAL PITFALL WHILE REDUCING THE MISMATCH BETWEEN LCP PLT AND UPPER END TIBIA IN PROXIMAL TIBIA FRACTURES. ARCH ORTHOP TRAUMA SURG (2010) 130:759-763. KOREA. THE STUDY OBJECTIVE WAS TO EVALUATE A MINIMALLY INVASIVE TECHNIQUE ALONG WITH PRE-CONTOURED LOCKING PLATES, ALIGNMENT RELATED PROBLEMS IN FRACTURES OF PROXIMAL TIBIA AND THE PITFALL IN THE RECOMMENDED TECHNIQUE AND STEPS TO BE TAKEN TO AVOID THIS ERROR. THE STUDY INCLUDED PATIENTS WHO WERE TREATED WITH LOCKING COMPRESSION PLATE- PROXIMAL LATERAL TIBIA (LCP PLT) WITH AGES FROM 38 TO 50 YEARS. ONE PATIENT, AN (B)(6) FEMALE, (B)(6), WITH FRACTURE TYPE 41-C2 WAS IMPLANTED WITH A PRE-CONTOURED LOCKING COMPRESSION PLATE - PROXIMAL LATERAL TIBIA (LCP PLT). POSTOPERATIVE X-RAY IN THIS PATIENT REVEALED A VALGUS MALALIGNMENT OF 10° (MEDIAL PROXIMAL TIBIA ANGLE, I.E., MPTA SHOWED A DIFFERENCE OF 10° WHEN COMPARED TO OPPOSITE NORMAL LIMB) EVEN THOUGH NORMAL ALIGNMENT WAS CONFIRMED PRIOR TO INSERTION OF THE PLATE. THIS PATIENT UNDERWENT A SECOND SURGERY AND AFTER CORRECTING THE ALIGNMENT, LCP PLT WAS REAPPLIED. THE ALIGNMENT WAS CORRECTED, BUT THE PLATE STOOD OFF THE BONE BY A FEW MILLIMETERS. NO ADDITIONAL SURGERIES WERE PERFORMED. THREE MORE CASES OF TYPES C1, C2, C1 WITH AGE 38, 48, 50 YEARS, RESPECTIVELY, WERE TREATED WITH THE SAME IMPLANT. A POST-OPERATIVE X-RAY REVEALED A VALGUS MALALIGNMENT OF 8, 10, AND 8ଠRESPECTIVELY IN THE THREE CASES. AN ADDITIONAL FINDING IN ALL THE CASES WAS THE MOST PROXIMAL SCREW THAT WAS TILTED IN VALGUS SUCH THAT THE TIP POINTED AWAY FROM THE JOINT LINE, A CONDITION WE DESCRIBED AS A VALGUS TILTING OF SCREW. CASE 2, FEMALE, AGE 45 YEARS TYPE C2 FRACTURE WAS REDUCED AND LCP PLT APPLIED ON THE LATERAL ASPECT OF TIBIA. POST-OPERATIVE X-RAY IN THESE CASES SHOWED A NORMAL ALIGNMENT (MPTA WITHIN 3° OF CONTRALATERAL NORMAL LIMB) AND THE PROXIMAL SCREW TILTED AWAY FROM THE JOINT LINE. THE PROXIMAL PART SAT PERFECTLY AGAINST THE BONE BUT THE DISTAL PART WAS A BIT AWAY. IN THREE CASES, AGE GROUP 40-50 YEARS, THE PLATE WAS SITTING PERFECTLY AGAINST THE PROXIMAL END OF BONE, BUT THE SCREW POINTED AWAY FROM JOINT LINE AND BONE WAS NORMALLY ALIGNED. IN ALL THESE EXAMPLES, THE PLATE HAD A VALGUS MALPOSITION, BUT THE BONE WAS NORMALLY ALIGNED IN POST-OPERATIVE X-RAYS. THE FOLLOWING COMPLICATIONS WERE REPORTED: THIS REPORT REFERS TO A PATIENT, FEMALE, (B)(6), WITH FRACTURE TYPE 41-C2 WHO WAS IMPLANTED WITH A PRE-CONTOURED LOCKING COMPRESSION PLATE - PROXIMAL LATERAL TIBIA (LCP PLT). POSTOPERATIVE X-RAY IN THIS PATIENT REVEALED A VALGUS MALALIGNMENT OF 10° (MEDIAL PROXIMAL TIBIA ANGLE, I.E., MPTA SHOWED A DIFFERENCE OF 10ࠗHEN COMPARED TO OPPOSITE NORMAL LIMB) EVEN THOUGH NORMAL ALIGNMENT WAS CONFIRMED PRIOR TO INSERTION OF THE PLATE. THIS PATIENT UNDERWENT A SECOND SURGERY AND AFTER CORRECTING THE ALIGNMENT, LCP PLT WAS REAPPLIED. THE ALIGNMENT WAS CORRECTED, BUT THE PLATE STOOD OFF THE BONE BY A FEW MILLIMETERS. NO ADDITIONAL SURGERIES WERE PERFORMED. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN LOCKING COMPRESSION PLATE-PROXIMAL LATERAL TIBIA (LCP PLT) UNKNOWN PART # / LOT #.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465072 PLATE,FIXATION,BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention