MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE 02.18.003LM ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM; KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED

Model Number 02.18.003LM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 09/27/2022

Event Type  Injury  

Event Description

Revision surgery performed 1 year and 2 months after the primary surgery due to pain.The surgeon revised all components with a total knee system (sphere).

Manufacturer Narrative

The olympus scope was sent to an independent laboratory for culture testing and results are still pending.The investigation is ongoing and follow up with the customer is currently being performed.After culture testing, the device will be evaluated.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

• Brand Name: MOTO PARTIAL KNEE 02.18.003LM ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM
• Type of Device: KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED
• 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: 15679998
• MDR Text Key: 302857998
• Report Number: 3005180920-2022-00787
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895579
• UDI-Public: 07630030895579
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K162084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.18.003LM
• Device Catalogue Number: 02.18.003LM
• Device Lot Number: 2004501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2020
• 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: 77 YR
• Patient Sex: Female
• Patient Race: White