MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM

Catalog Number	02.07.0217SCF
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2017 the (b)(6) manager performed a visual inspection of the explanted uhmwpe insert and commented as follows: the posterior "clipping" features of the insert have been plastically deformed and damaged in the lateral side.It presents a sort of incision with the negative shape of the clipping "tooth" of the baseplate.We can suppose that probably, in the first attempt to fix the insert into the baseplate, the insert was not posteriorly well positioned.In this attempt the insert was pushed posteriorly and was permanently damaged without possibility to be clipped in the following attempts.We can state that the event is not implant related.Some scratches can be identified on the anterior surface of the insert as well, most likely caused during the attempt to explant the component.Batch reviews performed on (b)(6) 2017.Lot 131096: (b)(4) items manufactured and released on 20 march 2013.Expiration date: 2018-01-31.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-revision fixed tibial tray cemented size 2 right, code 02.07.0682r, lot.164179 (k123721) (b)(4) items manufactured and released on 04 october 2016.Expiration date: 2021-09-20.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
When implanting the insert, the insert would not seat properly.The surgeon requested a secondary insert to complete the surgery.There was approximately a 5 minute delay in surgery.The surgery was completed successfully.Implant is available.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6860922
• Report Number: 3005180920-2017-00516
• Device Sequence Number: 19184418
• Product Code: JWH
• UDI-Device Identifier: 07630030816833
• UDI-Public: 07630030816833
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 02.07.0217SCF
• Device Lot Number: 131096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 09/13/2017
• 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: Other