MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 8MM 02.18.IF5.08.LM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-04 for MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 8MM 02.18.IF5.08.LM manufactured by Medacta International Sa.

MAUDE Entry Details

• Report Number: 3005180920-2020-00133
• MDR Report Key: 9785501
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2020-03-04
• Date of Report: 2020-03-04
• Date of Event: 2020-02-07
• Date Mfgr Received: 2020-02-07
• Device Manufacturer Date: 2019-07-15
• Date Added to Maude: 2020-03-04
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR STEFANO BAJ
• Manufacturer Street: STRADA REGINA
• Manufacturer City: CASTEL SAN PIETRO, SWITZERLAND 6874
• Manufacturer Country: SZ
• Manufacturer Postal: 6874
• Manufacturer G1: MEDACTA INTERNATIONAL SA
• Manufacturer Street: STRADA REGINA
• Manufacturer City: CASTEL SAN PIETRO, 6874
• Manufacturer Country: SZ
• Manufacturer Postal Code: 6874
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 8MM
• Generic Name: KNEE PARTIAL TIBIAL INSERT
• Product Code: HSX
• Date Received: 2020-03-04
• Model Number: 02.18.IF5.08.LM
• Catalog Number: 02.18.IF5.08.LM
• Lot Number: 1903787
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDACTA INTERNATIONAL SA
• Manufacturer Address: STRADA REGINA CASTEL SAN PIETRO, 6874 SZ 6874

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-04