MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM; KNEE UNICOMPARTIMENTAL FEMORAL COMPONENT CEMENTED

Catalog Number 02.18.003LM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Implant Pain (4561)

Event Date 05/05/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 12 may 2022: lot 2101833: (b)(4) items manufactured and released on 08-apr-2021.Expiration date: 2026-03-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional components involved: moto partial knee 02.18.Tf5.Lm tibial tray fix cemented s5 lm (k162084) lot.2012121: (b)(4) items manufactured and released on 09-march-2021.Expiration date: 2026-02-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event.Moto partial knee 02.18.If5.09.Lm tibial insert fix s5 lm - 9mm (k162084) lot.1910833: (b)(4) items manufactured and released on 26-feb-2020.Expiration date: 2025-02-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

Event Description

Revision surgery at about 8 months from primary for knee pain.During the revision surgery the implants were assessed, well fixed , and positioned perfectly.All components revised successfully.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM
• Type of Device: KNEE UNICOMPARTIMENTAL FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14546964
• MDR Text Key: 292962186
• Report Number: 3005180920-2022-00420
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.18.003LM
• Device Lot Number: 2101833
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male