MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 14 MM

Catalog Number	02.07.0214FUC
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 may 2018 lot 134898: 30 items manufactured and released on 16 january 2014.Expiration date: 2018-11-30.No anomalies found related to the problem.To date, 21 items of the same lot have been already sold without any similar reported event.Gmk-primary femur cemented std size 3 narrow / right reference (b)(4).Lot 150964: 35 items manufactured and released on 03 june 2015.Expiration date: 2020-04-30 no anomalies found related to the problem.To date, 34 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in complaining of instability 8 months after primary and the 12mm insert was revised with a 14mm.The patient became loose over time.(mdr 2016-00539) the patient came in again 1 year and 7 months later, complaining of anterior knee pain.The patient was a little loose, so the 14mm poly was replaced with a 17mm and resurfaced the patella.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 14 MM
• Common Device Name: TIBIAL INSERT UC FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7494739
• Report Number: 3005180920-2018-00304
• Device Sequence Number: 18880604
• Product Code: JWH
• UDI-Device Identifier: 07630030816659
• UDI-Public: 07630030816659
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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: 11/30/2018
• Device Catalogue Number: 02.07.0214FUC
• Device Lot Number: 134898
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/08/2018
• 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
• Patient Age: 47 YR