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

Catalog Number	02.09.0214H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received on (b)(6) 2017 and includes: only the screw of the inlay is available for investigation.The implants have been taken out successfully.Batch reviews performed on (b)(6) 2017.Lot 143009: (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 and this is the second similar event reported on the same lot.Gmk-hinge extension stem - cemented ø 16 l 105, code 02.07.Fsc16105, lot.153084 (k120790) (b)(4) items manufactured and released on 21 september 2015.Expiration date: 2020-08-24.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.Gmk-hinge extension stem - cemented ø 13 l 65, code 02.07.Fsc13065, lot.154981 (k120790) (b)(4) items manufactured and released on 26 october 2015.Expiration date: 2020-10-12.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.Gmk-hinge femoral wedge distal size 3/4mm, code 02.07.304fdw, lot.130766 (k102437) (b)(4) items manufactured and released on 10 april 2013.Expiration date: 2018-02-28.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.Gmk-hinge offset connector 5 mm, code 02.07.0005, lot.153101 (k102437) (b)(4) items manufactured and released on 23 november 2015.Expiration date: 2020-10-18.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Gmk-hinge fixed tibial tray size 2 left, code 02.09.4002l, lot.154267 (k130299) (b)(4) items manufactured and released on 08 september 2015.Expiration date: 2020-07-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold and this is the second similar event reported on items of the same lot.Gmk-hinge femoral wedge posterior size 3/5mm, code 02.05.03pw, lot.144460 (k102437) (b)(4) items manufactured and released on 01 july 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.Gmk-hinge femoral component size 3 left, code 02.09.2603l, lot.153057 (k130299) (b)(4) items manufactured and released on 23 september 2015.Expiration date: 2020-07-31.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.Gmk-hinge femoral wedge posterior size 3/5mm, code 02.05.03pw, lot.125264 (k102437) (b)(4) items manufactured and released on 29 january 2013.Expiration date: 2017-12-31.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.Gmk-hinge offset connector 3 mm, code 02.07.0003, lot.155902 (k102437) (b)(4) items manufactured and released on 19 october 2015.Expiration date: 2020-10-03.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.Gmk-primary patella resurfacing size 3, code 02.07.0035rp, lot.156396 (k090988) (b)(4) items manufactured and released on 10 february 2016.Expiration date: 2021-01-27.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.Not yet received.
Event or Problem Description
During a revision of gmk hinge implants due to infection, the surgeon noticed that the screw of the inlay was broken.
Additional Manufacturer Narrative
On 24 august 2017 the r&d project manager performed a visual inspection of the retrieved screw and commented as follows: the screw is found broken in correspondence to the second threads of its threaded shaft.This corresponds to the part of the screw that sticks out from the baseplate.The remaining part of the screw is not available since left inside the tibia baseplate.The part of the screw removed by arthroscopy is not damaged.The screw was most likely found into the insert and not loosened in the joint.We can so suppose that the articular surface of the femur and the insert have not been damaged by the screw.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6672558
• Report Number: 3005180920-2017-00340
• Device Sequence Number: 16347898
• Product Code: KRO
• UDI-Device Identifier: 07630030825064
• UDI-Public: 07630030825064
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K130299
• 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,Followup
• Report Date (Section B): 08/30/2017

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: 06/30/2019
• Device Catalogue Number: 02.09.0214H
• Device Lot Number: 143009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2017
• Supplement Date Received by Manufacturer: 05/29/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 08/30/2017
• 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
• Patient Age: 76 YR