BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBALANCE UKA TIBIAL BEARING, SIZE 4, 8MM

    MDR report key: 5457787 · Received February 24, 2016

    Report

    Report Number
    1220246-2016-00100
    Event Type
    Injury
    Date Received
    February 24, 2016
    Date of Event
    February 1, 2016
    Report Date
    February 3, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    JWH
    PMA / PMN Number
    K081127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (DATE OF BIRTH, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. THIS IS ONE OF THREE SUBMISSIONS FROM THE SAME EVENT. THE OTHER TWO ARE CC81731-00070-LINE 152722 AND CC81731-00099-LINE 152724. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THE DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THE EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE EXPECTED BUT NOT YET RETURNED.

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (DATE OF BIRTH, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. THIS IS ONE OF THREE SUBMISSIONS FROM THE SAME EVENT. (B)(4). NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THE EVENT. THE EVALUATION REVEALED THAT THE RETURNED DEVICE MATERIAL IS DEFORMED IN THE SLOT AREAS AND EDGES. YELLOW DISCOLORATION AND DEEP GOUGE MARKS/SCRATCHES WAS OBSERVED ON THE ARTICULATING SURFACE AND POSTERIOR SURFACE. THE DAMAGED OBSERVED ON DEVICE MAY HAVE BEEN CAUSED BY THE REMOVAL OF BEARING DURING THE REVISION SURGERY. THE EVALUATION DID NOT REVEAL ANYTHING RELEVANT TO THE EVENT, THE CAUSE FOR THE REVISION SURGERY IS UNDETERMINED. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A RIGHT MEDIAL UNI-COMPARTMENTAL REPLACEMENT ON (B)(6) 2014 USING THE ARTHREX UKA SYSTEM. PATIENT REPORTED TO SURGEON THAT HIS KNEE HAD STARTED LOCKING AND GIVING OUT WITH PAIN. THE PAIN WAS LATERAL AND MEDIAL WITH PAIN IN THE POSTERIOR CAPSULE OF THE KNEE. PATIENT REPORTED NO PAIN AT NIGHT. PAIN SEEMED TO BE RELATED TO ACTIVITY. PRIOR TO THE REVISION THE PATIENT HAD AN ASPIRATION AND INJECTION. THE FLUID WAS SENT FOR CELL COUNT AND CULTURES AND WAS NEGATIVE FOR INFECTION. PAIN CONTINUED AND PATIENT REPORTED ONLY HAVING ONE DAY OF RELIEF FROM THE INJECTION. UPON EXAMINATION PRIOR TO THE REVISION, PALPATION OF THE RIGHT KNEE DEMONSTRATED INFERIOR PATELLAR POLE TENDERNESS, MEDIAL JOINT LINE TENDERNESS AND LATERAL JOINT LINE TENDERNESS. THERE WAS MILD EFFUSION OF THE RIGHT KNEE. PATIENT HAD PAIN WITH FLEXION AND EXTENSION. ON (B)(6) 2016 PATIENT HAD A REVISION SURGERY TO CONVERT THE RIGHT KNEE MEDIAL UNI-COMPARTMENTAL TO A FULL RIGHT TOTAL KNEE REPLACEMENT. DURING THE REVISION THE ORIGINAL TIBIAL TRAY AR-501-TTRD ( LOT 108761134) WAS EXPLANTED ALONG WITH THE FOLLOWING ORIGINAL IMPLANTS: FEMORAL IMPLANT AR-UFRE (LOT 108761228) AND TIBIAL BEARING AR-501-TBD8 (LOT 1136011212). TOTAL KNEE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURERS PRODUCTS. EXPLANTED DEVICES ARE BEING RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A RIGHT MEDIAL UNI-COMPARTMENTAL REPLACEMENT ON (B)(6) 2014 USING THE ARTHREX UKA SYSTEM. PATIENT REPORTED TO SURGEON THAT HIS KNEE HAD STARTED LOCKING AND GIVING OUT WITH PAIN. THE PAIN WAS LATERAL AND MEDIAL WITH PAIN IN THE POSTERIOR CAPSULE OF THE KNEE. PATIENT REPORTED NO PAIN AT NIGHT. PAIN SEEMED TO BE RELATED TO ACTIVITY. PRIOR TO THE REVISION THE PATIENT HAD AN ASPIRATION AND INJECTION. THE FLUID WAS SENT FOR CELL COUNT AND CULTURES AND WAS NEGATIVE FOR INFECTION. PAIN CONTINUED AND PATIENT REPORTED ONLY HAVING ONE DAY OF RELIEF FROM THE INJECTION. UPON EXAMINATION PRIOR TO THE REVISION, PALPATION OF THE RIGHT KNEE DEMONSTATED INFERIOR PATELLAR POLE TENDERNESS, MEDIAL JOINT LINE TENDERNESS AND LATERAL JOINT LINE TENDERNESS. THERE WAS MILD EFFUSION OF THE RIGHT KNEE. PATIENT HAD PAIN WITH FLEXION AND EXTENSION. ON (B)(6) 2016 PATIENT HAD A REVISION SURGERY TO CONVERT THE RIGHT KNEE MEDIAL UNI-COMPARTMENTAL TO A FULL RIGHT TOTAL KNEE REPLACEMENT. DURING THE REVISION THE ORIGINAL TIBIAL TRAY AR-501-TTRD (LOT 108761134) WAS EXPLANTED ALONG WITH THE FOLLOWING ORIGINAL IMPLANTS: FEMORAL IMPLANT AR-UFRE (LOT 108761228) AND TIBIAL BEARING AR-501-TBD8 (LOT 1136011212). TOTAL KNEE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURERS PRODUCTS. EXPLANTED DEVICES ARE BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112963 IBALANCE UKA TIBIAL BEARING, SIZE 4, 8MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH ARTHREX, INC. 113601212

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other