MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 LM; KNEE FEMORAL COMPONENT CEMENTED UNICOMPARTIMENTAL

Model Number	02.18.005LM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 september 2022: lot 2004507: (b)(4) items manufactured and released on 20-july-2020.Expiration date: 2025-07-08.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 device involved.Batch review performed on 08 september 2022: moto partial knee 02.18.Tf4.Lm tibial tray fix cemented s4 lm (k162084) lot 2105879: (b)(4) items manufactured and released on 20-july-2020.Expiration date: 2026-07-20.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.Clinical evaluation performed by medacta medical affairs director: few months after primary cemented uka, the patient reports pain and revision is required.Both components are mobilized, and according to the report there was no cement on the bone, while the metal parts were well embedded in cement.This may well be a cause for early mobilization, and in that case it should be related to a problem occurred during cementation, such as an expected delay between cement mixing and bone application, or unexpectedly high temperature in the operating room that made the cement cure faster than expected.No reason to suspect a faulty device at the origin of this problem.
Event or Problem Description
During a follow-up visit, the patient reported pain at the tibial component.At about 7 months after the primary, the revision surgery was performed and during the revision it was noted the loosening of both tibial and femoral components and that no cement was present on the bone of the patient.The surgeon revised successfully all components and implanted gmk sphere system.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 LM
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED UNICOMPARTIMENTAL
• 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: 15549033
• Report Number: 3005180920-2022-00744
• Device Sequence Number: 1806427
• Product Code: HSX
• UDI-Device Identifier: 07630030895616
• UDI-Public: 07630030895616
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2022

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: 07/08/2025
• Device Model Number: 02.18.005LM
• Device Catalogue Number: 02.18.005LM
• Device Lot Number: 2004507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2020
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White