MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC # 3/23MM

Catalog Number	02.07.0323SCF
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs on 23 march 2018; secondary instability in a patient with a long history of tka revisions and infections.The instability is due to retinacular tear, according to report, and a thicker insert was used to gain articular stability.The cause for reoperation should not be sought in a defective device.Batch review performed on 03 april 2018; lot 134148: (b)(4) items manufactured and released on 13 november 2013.Expiration date: 2018-09-30; no anomalies found related to the problem.To date,(b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery performed due to knee instability, the cause of the instability is due to a retinacular tear (about 1 month from primary).The surgeon up sized the poly of 3mm.The patient was already underwent to different surgeries due to multiple infections before this revision.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC # 3/23MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7395350
• Report Number: 3005180920-2018-00199
• Device Sequence Number: 1051781
• Product Code: JWH
• UDI-Device Identifier: 07630030817557
• UDI-Public: 07630030817557
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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: 09/30/2018
• Device Catalogue Number: 02.07.0323SCF
• Device Lot Number: 134148
• 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: 03/05/2018
• Initial Report FDA Received Date: 04/04/2018
• 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: 66 YR