MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FIXED TIBIAL INSERT SC SIZE 5/20MM

Catalog Number	02.07.0520SCF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 december2018, lot 121809: (b)(4).Expiration date: 2017-08-31 no anomalies found related to the problem.(b)(4).
Event or Problem Description
About 3 years after primary the surgeon revised the patient for knee infection.I&d and insert swap performed successfully.

• Brand Name: GMK-PRIMARY FIXED TIBIAL INSERT SC SIZE 5/20MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8184573
• Report Number: 3005180920-2018-01021
• Device Sequence Number: 2792699
• Product Code: JWH
• UDI-Device Identifier: 07630030818677
• UDI-Public: 07630030818677
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 02.07.0520SCF
• Device Lot Number: 121809
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention