MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM

Catalog Number	02.07.0312PSF
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 march 2018; lot 133286: (b)(4) items manufactured and released on 25 september 2013.Expiration date: 2018-08-31.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
The surgeon notified sales representative on (b)(6) 2018 that the patient came in complaining of instability.The surgeon determined the patient was loose in flexion and extension.The surgeon plans to revise the poly on (b)(6) 2018.On (b)(6) 2018 we were informed that this case is cancelled until further notice.The patient has been smoking and thus cannot perform surgery.
Additional Manufacturer Narrative
Additional information received on 08 may 2018: the patient was revised on(b)(6) 2018.The surgeon swapped the poly with a thicker one (ref 02.07.0317psf).The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM
• Common Device Name: TIBIAL INSERT PS FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7362185
• Report Number: 3005180920-2018-00173
• Device Sequence Number: 1426666
• Product Code: JWH
• UDI-Device Identifier: 07630030817168
• UDI-Public: 07630030817168
• 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: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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: 08/31/2018
• Device Catalogue Number: 02.07.0312PSF
• Device Lot Number: 133286
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 05/30/2018
• 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: 48 YR