MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 5/12MM

Catalog Number	02.09.0512H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 september 2018.Lot 120031ar: (b)(4) items manufactured and released on 02 april 2014.Expiration date: 2017-04-30 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
We were informed on 17 august 2018 that a patient came in complaining of pain.The surgeon believes the poly is loose.The surgeon plans to revise on (b)(6) 2018.More information to follow the case.Update 21 august 2018: on (b)(6) 2018, during surgery, the surgeon determined that the poly fixation screw broke.The surgeon left everything as is, the screw was not retrieved.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 5/12MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7876591
• Report Number: 3005180920-2018-00689
• Device Sequence Number: 192300
• Product Code: KRO
• UDI-Device Identifier: 07630030825262
• UDI-Public: 07630030825262
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• 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): 09/14/2018

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: 04/30/2017
• Device Catalogue Number: 02.09.0512H
• Device Lot Number: 120031AR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/14/2018
• 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