MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L

Model Number	02.12.0413FL
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 16 march 2020: lot 166495: (b)(4) items manufactured and released on 13-dec-2016.Expiration date: 2021-11-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved in the event, batch review performed by medacta.Regulatory.Affairs department on 16 march 2020: gmk-sphere 02.12.0410fr tibial insert fixed sphere flex size 4/10 mm r (k121416).Lot 166520: (b)(4) items manufactured and released on 09-dec-2016.Expiration date: 2021-11-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.
Event or Problem Description
After 1 year and 3 months from the previous revision, the patient came in reporting pain due to laxity in both knees.The surgeon revised the left knee from a medacta sphere insert flex left 13mm s4 to a medacta sphere insert flex left 17mm s4 and revised the right knee from a medacta sphere insert flex right 10mm s4 to a medacta sphere insert flex right 12mm s4.The surgeon also resurfaced both patella's.The surgery was completed successfully.This is the second revision surgery for this patient (during the previous revision surgery due to laxity in the left knee, the extension stem, insert and tibial tray were revised).
Additional Manufacturer Narrative
Patient match planning review perfomed by medacta mysolution manager: left side: images qc: the dataset fully respects the protocol.The images were not expired at the time of the surgery (see the screenshot below of the report of the qc reconstruction: the reconstructed profile follows precisely the contour of the bone.Planning - landmarks: all the landmarks were taken accordingly to the process.Pre-op information: as per the other cases, the only information available to the my knee team was about the bones.No pre-op information was available regarding: the status of the ligaments: this information, as for all the cases, is available just to the surgeon; the thickness of the cartilage: this information is not available, since this case is ct- based.Planning proposal: in the planning proposal, all the chosen parameters are within the range of preferences set by the surgeon on the website.Planning - validation: our planning proposal went into automatic validation without any change in the parameters.Femoral cutting block: all the pads are in contact with parts that cannot get detached.Tibial cutting block: all the pads are in contact with parts that cannot get detached.Extra-analysis: no extra-analysis is possible, since we have not received any x-ray.Conclusions: our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.Right side: images qc: the dataset fully respects the protocol.The images were not expired at the time of the surgery.Reconstruction: the reconstructed profile follows precisely the contour of the bone.Planning - landmarks: all the landmarks were taken accordingly to the process.Pre-op information: as per the other cases, the only information available to the my knee team was about the bones.No pre-op information was available regarding: the status of the ligaments: this information, as for all the cases, is available just to the surgeon.The thickness of the cartilage: this information is not available, since this case is ct- based.Planning proposal: in the planning proposal, all the chosen parameters are within the range of preferences set by the surgeon on the website.Planning - validation: our planning proposal went into automatic validation without any change in the parameters.Femoral cutting block: all the pads are in contact with parts that cannot get detached.Tibial cutting block: all the pads are in contact with parts that cannot get detached.Extra-analysis: no extra-analysis is possible, since we have not received any x-ray.Conclusions: our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9920579
• Report Number: 3005180920-2020-00210
• Device Sequence Number: 3435641
• Product Code: JWH
• UDI-Device Identifier: 07630030862618
• UDI-Public: 07630030862618
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/23/2021
• Device Model Number: 02.12.0413FL
• Device Catalogue Number: 02.12.0413FL
• Device Lot Number: 166495
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR