MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE E-CROSS TIBIAL INSERT FIX S6 - LATERAL - 8M; KNEE TIBIAL INSERT

Catalog Number	02.18.EIF6.08.LLRL
Medical Device Problem Codes	Malposition of Device (2616); Naturally Worn (2988)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed about 7 months after the primary surgery due to tibial baseplate being too medialised and causing lateral impingement.Upon removing the tibial baseplate and poly, significant poly wear was found.Tibial components have been downsized to a size 5 from a size 6, and from 8mm to 11mm poly.Note that the insert disengaged from the baseplate during the revision surgery, it was not disengaged while inside the patient and was correctly clipped during the primary surgery.
Additional Manufacturer Narrative
Batch review performed on 16 july 2024: lot 2110530: (b)(4) items manufactured and released on 13-dec-2021.Expiration date: 2026-nov-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional device involved: batch review performed on 16 july 2024.Lot 2238965: (b)(4) items manufactured and released on 25-jan-2023.Expiration date: 2028-jan-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs manager: a few months after primary uka, the position of the tibial component is found to be suboptimal, and partial replacement (tibia only) is undertaken.At removal, in addition to the feeling of impingement due to the component's position, significant wear is found.After few months, this is a certain indicator that third bodies were trapped in the articulation.There is no mention of damage to the femoral component, so we can assume that the bodies were of semi-soft materials (such as cement), able to scratch the pe insert but not the co-alloy of the femoral component.From the evidence supplied, we do not see any reason to suspect a defective device at the origin of this reoperation.Investigation performed by medacta r&d knee project manager: revision surgery of a moto lateral baseplate after 8 months from primary implantation due to pain for lateral overhang.During the revision surgery, only the tibial baseplate and the poly liner has been revised.A smaller size was implanted.During the revision surgery, abnormal wear was noted on the e-cross insert.From inspection based on the picture of the removed components, several scratches and dents can be noted on articular surface of the insert.Those are signs most likely related to a third body present in the articulation that presumably damaged the tibial insert and didn't damage the cocr femoral component that was not revised.We can notice a lot of cement present on the medial side of the component, almost reaching the level of the articular surface.It was not cleaned after impaction of the baseplate.Here the possibility that some cement debris could have then caused the early damage of the insert articular surface.We can also notice that the inlay have been cut on the posterior medial side; it is not clear when and why this cut was performed.From inspection, there is no evidence that the event is related to a faulty device; it is likely related to malpositioning and possible oversizing of the tibia component.
Additional Manufacturer Narrative
Piece returned on 19 aug 2024.Visual inspection performed by r&d project manager: revision surgery of a moto lateral baseplate after 8 months from primary implantation due to pain for lateral overhang.During the revision surgery, only the tibial baseplate and the poly liner has been revised.A smaller size was implanted.During the revision surgery, abnormal wear was noted on the e-cross insert.From visual inspection of the explanted components sent back for investigation, we can notice several scratches and dents on articular surface of the insert.Those are signs most likely related to a third body present in the articulation that presumably damaged the tibial insert and didn't damage the cocr femoral component that was not revised.We can notice residual cement present on the medial side of the component, almost reaching the level of the articular surface.It was not cleaned after impaction of the baseplate.Here the possibility that some cement debris could have then caused the early damage of the insert articular surface.We can also notice that the inlay have been cut on the posterior medial side; we guess this has been done during the revision case with a saw blade to remove the cement from the medial side of the baseplate.From visual inspection, there is no evidence that the event is related to a faulty device; the event is likely related to malpositioning and/or oversizing of the tibia component.

• Brand Name: MOTO PARTIAL KNEE E-CROSS TIBIAL INSERT FIX S6 - LATERAL - 8M
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19826343
• Report Number: 3005180920-2024-00543
• Device Sequence Number: 12928052
• Product Code: HSX
• UDI-Device Identifier: 07630345712097
• UDI-Public: 07630345712097
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K213071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02.18.EIF6.08.LLRL
• Device Lot Number: 2110530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown