MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/23MM

Catalog Number	02.09.0423H
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 may 2018; lot 143026: (b)(4) items manufactured and released on 16 july 2014.Expiration date: 2019-06-30; 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.Other device involved: gmk-hinge fixed tibial tray size 4 l reference 02.09.4004l (k130299); lot 120940: (b)(4) items manufactured and released on 12 july 2012.Expiration date: 2017-05-31; 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
The patient had a revision surgery ((b)(6) 2017) due to inlay locking screw breakage and insert intra-prosthetic dislocation.The surgeon burred the screw thread, that was remained in the tibial component, to successfully implant another insert plus screw, (b)(4) was filed.In (b)(6) 2018, 3 years and 5 months after primary, the inlay locking screw unscrewed, the inlay and post yolk dislocated from the tibia remaining assembled among them.Note: the patient had an amputation on the non-operative side before the primary surgery.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 01 june 2018: partial disassembly of a hinge knee in a severely deficient patient, amputee on the contralateral side.According to report, the mechanical integrity of the device was damaged and required re-intervention.The insert screw was placed in a tibial baseplate that had been previously burred for screw substitution.This may have hindered screw retention but no data is available on such a situation.We cannot determine the root cause of this complex case.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 4/23MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7553219
• Report Number: 3005180920-2018-00386
• Device Sequence Number: 16179053
• Product Code: KRO
• UDI-Device Identifier: 07630030825231
• UDI-Public: 07630030825231
• 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: 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): 06/26/2018

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: 06/30/2019
• Device Catalogue Number: 02.09.0423H
• Device Lot Number: 143026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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: 67 YR