MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/14MM

Catalog Number	02.09.0414H
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	06/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received on 13 june 2017 and includes: the explants are not available for further investigation.The torque limiter was used during primary surgery for the inlay fixation.Batch review performed on 06 july 2017.(b)(4).
Event or Problem Description
The patient had pain because of a patella tilt and patella problems in general.On the x-ray, it was seen that the screw backed out from the inlay.The revision surgery is scheduled for the (b)(6) 2017.The surgeon planned to remove patella and insert.
Additional Manufacturer Narrative
On 10 july 2017 we received details concerning the revision surgery, performed on that day: inlay changed, patella resurfacing done.Screw partwise explanted and the new screw fitted not 100%, but they left it like this.Else it would have caused a tibia revision - which was not an option to execute.
Additional Manufacturer Narrative
On 07 september 2017 the r&d project manager performed a visual inspection of the explanted components and commented as follows: gmk-hinge secure inlay screw: the screw was found loosened in the joint after few months from implantation and not broken as supposed from x-rays analysis.The last thread of the screw is damaged and plastically deformed.The other part of the screw looks intact, without any defects or damages.It is not possible to find an explanation for this event.A torque limiting screwdriver (3 nm) is supplied and its use is mandatory in order to achieve the tightening torque.The only cause that we can suppose, but not possible to be verified, for this event is insufficient tightening torque, either due to a malfunction of the torque limiting device or to improper use (limiting torque was not reached).Tibia insert: the insert seems to be deformed with the central cone ovalized, most likely because of the autoclave sterilization process after explantation.It present some scratches is most likely caused during the attempt to explant the inlay from the baseplate.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 4/14MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6692963
• Report Number: 3005180920-2017-00365
• Device Sequence Number: 772362
• Product Code: KRO
• UDI-Device Identifier: 07630030825200
• UDI-Public: 07630030825200
• 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,Followup
• Report Date (Section B): 09/08/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 02.09.0414H
• Device Lot Number: 143023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 06/09/2017; 06/09/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/03/2017; 09/08/2017
• 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: 61 YR