MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM; KNEE TIBIAL INSERT

Catalog Number	02.09.0214H
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 june 2019: lot 135260: (b)(4) items manufactured and released on 17-feb-2014.Expiration date: 2018-11-30.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 1 year and 7 months after primary due to post-screw unscrewing.All hardware has been removed.The locking screw of the inlay was in the correct place.
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs director on (b)(6) 2019: 1,5 years after revision tka the screw that holds together the two components got loose.We could not identify, until now, a possible cause for this event.One possibility, verified in a similar situation, is insufficient tightening torque at the time of surgery, but other conditions may also play a determinant role.We are unable to find a conclusive clinical cause for this event.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8762662
• Report Number: 3005180920-2019-00532
• Device Sequence Number: 16653952
• Product Code: KRO
• UDI-Device Identifier: 07630030825064
• UDI-Public: 07630030825064
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 02.09.0214H
• Device Lot Number: 135260
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 07/04/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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: Other