MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 RM

Model Number	02.18.TF2.RM
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 29 may 2020: lot 1902962: (b)(4) items manufactured and released on 20-sep-2019.Expiration date: 2024-09-10.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.Clinical evaluation performed by medacta medical affairs director: revision surgery performed 4 months after unicompartmental knee arthroplasty due to a tibial fracture in a (b)(6) year old woman.Early fracture may be caused by a sudden movement on a weakened bone due to normal tibial preparation or to the presence of a subclinical intraoperative fracture.There is no reason to suspect a faulty device.Preliminary investigation performed by medacta r&d knee manager: revision surgery of a medial unicompartmental knee due to post-op bone fracture of the medial tibial head.From the picture of the explanted components, any anomalies or damages occurred prior to or after primary surgery can't be revealed.The frontal locking mechanism of the tibial insert was damages most likely in the procedure of removal of the implant.Reason for bone fracture remains unknown.There is no evidence that it is related to a faulty device.
Event or Problem Description
Subsidence of the tibial tray, due to post-op fracture (the root cause of the bone fracture is unknown) of the medial tibial head.4 months after primary the surgeon revised all implants to gmk sphere.
Additional Manufacturer Narrative
On (b)(6) 2020 we received the planning review form my solution department.Planning review performed by my solution department.We analyzed each step of the myknee process.No errors have been found in the myknee process.Here below you can find the detailed analysis of the process: 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: the surgeon performed and validated a rev.1.Planning: choice of the size: size 2 for the femur and size 2 for the tibia.No information is available regarding the implanted sizes.Femoral guide: there is no guide, since it is an uni implant.Tibial guide: all the pads are in contact with parts that cannot get detached.Implant positioning: tibia: profile of the implant show how the prosthesis would fit with validated revision.Implant positioning: femur: profile of the implant show how the prosthesis would fit with validated revision.Extra-analysis: we received just a radiography showing a lateral view of the a very bent leg.This is not usable for any extra-analysis 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: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 RM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10161544
• Report Number: 3005180920-2020-00334
• Device Sequence Number: 11426450
• Product Code: HSX
• UDI-Device Identifier: 07630030896729
• UDI-Public: 07630030896729
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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: 09/10/2024
• Device Model Number: 02.18.TF2.RM
• Device Catalogue Number: 02.18.TF2.RM
• Device Lot Number: 1902962
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/17/2020
• 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: 69 YR