MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM; FIXED TIBIAL INSERT

Catalog Number	02.07.0310PSF
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient match planning review performed on (b)(6) 2017 by patient's match department.Our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.No extra-analysis is possible, since we have not received any x-ray.Batch review performed on 04 december 2017.Lot 157428: sixty (60) items manufactured and released on 18 mar 2016.Expiration date: 2021-03-07.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient had a primary surgery with myknee in (b)(6) 2016.The patient was unable to complete physical therapy due to illness.The patient came in complaining of stiffness.On (b)(6) 2017 the surgeon removed/released the soft tissue that hampered flexion and swapped the insert.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7086824
• Report Number: 3005180920-2017-00723
• Device Sequence Number: 19199054
• Product Code: JWH
• UDI-Device Identifier: 07630030817069
• UDI-Public: 07630030817069
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2017

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: 03/07/2021
• Device Catalogue Number: 02.07.0310PSF
• Device Lot Number: 157428
• 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: 11/06/2017
• Initial Report FDA Received Date: 12/06/2017
• 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