MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 3/26MM

Catalog Number	02.09.0326H
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 may 2019: lot 143020: (b)(4) items manufactured and released on 11-jul-2014.Expiration date: 2019-05-31.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
On april 09th 2019 we were alerted that a patient was revised on (b)(6) 2019 due to hinge implant dislocation.The poly screw appears to be broken in the x-rays.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: dislocation of a constrained tka after 2.5 years in a very demanding case that is most probably a revision or re-revision of former failed treatments.In the lateral image, we think that we see the pe insert completely dislocated from the tibial baseplate.For such an event to happen, unprecedented in this form to our knowledge, a very relevant joint distraction must have taken place, which indicates total laxity of the remaining collateral ligaments (if at all present) and patellar mechanism, along with the other soft tissues around the joint.Dislocation probably also caused fracture of the small insert screw.The general boundary conditions of this event cannot be fully evaluated with the information at hand.It seems an exceptional event in exceptional conditions.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 3/26MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8599744
• Report Number: 3005180920-2019-00349
• Device Sequence Number: 19335595
• Product Code: KRO
• UDI-Device Identifier: 07630030825170
• UDI-Public: 07630030825170
• 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: 2016
• 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): 06/05/2019

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: 05/31/2019
• Device Catalogue Number: 02.09.0326H
• Device Lot Number: 143020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/05/2019
• 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: Required Intervention