MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 LM - 8MM; UNICOMPARTIMENTAL KNEE INSERT

Model Number	02.18.IF2.08.LM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 october 2022 lot 181335: (b)(4) items manufactured and released on 18-june-2018.Expiration date: 2023-05-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional components involved in the event: moto partial knee 02.18.001lm anatomical femoral component cemented s1 lm (k162084) lot.170766: (b)(4) items manufactured and released on 09-may-2017.Expiration date: 2022-04-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Moto partial knee 02.18.Tf2.Lm tibial tray fix cemented s2 lm lot.187643: (b)(4) items manufactured and released on 21-nov-2018.Expiration date: 2023-11-07.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2019.On (b)(6) 2020, the patient came in reporting tightness of the knee.The surgeon revised the 10mm poly with an 8mm poly and the surgery was completed successfully.Presently, on (b)(6) 2022, the patient came in for a post-op appointment and the surgeon observed that the patient was very valgus and the knee was very lax.The surgeon revised all components and the surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 LM - 8MM
• Common Device Name: UNICOMPARTIMENTAL KNEE 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15657370
• Report Number: 3005180920-2022-00802
• Device Sequence Number: 12356661
• Product Code: HSX
• UDI-Device Identifier: 07630030895852
• UDI-Public: 07630030895852
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2022

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: 05/16/2023
• Device Model Number: 02.18.IF2.08.LM
• Device Catalogue Number: 02.18.IF2.08.LM
• Device Lot Number: 181335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2018
• 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
• Patient Sex: Female