MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE4 / 10 MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0410FUC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 may 2019.Lot 130443: (b)(4) items manufactured and released on 22-mar-2013.Expiration date: 2018-02-28.No anomalies found related to the problem.To date, all the items of the same lot have been already sold with another similar reported event (complaint: (b)(4); mdr: 2018-00821).Additional implants involved (not marketed in us): gmk-primary 02.07.1304r tibial tray fixed cementless size 4 r, lot 124580: (b)(4) items manufactured and released on 17-jan-2013.Expiration date: 2017-12-31.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.Gmk-primary 02.07.2304r femur std cementless size 4 r, lot: 125546: (b)(4) items manufactured and released on 07-feb-2013.Expiration date: 2017-12-31.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Additional surgery performed 5 years and 1 month after the primary due to knee infection.The knee was washed out.

• Brand Name: GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE4 / 10 MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8607923
• Report Number: 3005180920-2019-00364
• Device Sequence Number: 11265353
• Product Code: JWH
• UDI-Device Identifier: 07630030817618
• UDI-Public: 07630030817618
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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: 02/28/2018
• Device Catalogue Number: 02.07.0410FUC
• Device Lot Number: 130443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2019
• Initial Report FDA Received Date: 05/14/2019
• 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