MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/14MM

Model Number	02.07.0314SCF
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by meedacta regulatory affairs department on 20 july 2020: lot 165111: (b)(4) items manufactured and released on 15-nov-2016.Expiration date: 2021-11-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation 3 years after revision tka the tibial component is painful and needs removal.Apparently, the main reason for this pain is the position of the stabilization stem, which is in contact with the lateral cortex.We have no postoperative images, so we cannot tell if this position was chosen by the surgeon originally (reasons unknown) or it is the result of a progressive deviation.No reason to suspect a faulty device to date.Another device involved in the event gmk-revision 02.07.1203r tibial tray fixed cemented # 3 r lot.167426 (k090988) batch review performed by meedacta regulatory affairs department on 20 july 2020: lot 167426: (b)(4) items manufactured and released on 28-mar-2017.Expiration date: 2022-03-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
Revision surgery performed about 3 years and 7 months after the primary surgery.The patient was having pain due to an impingement of the extension stem and the tibial bone.A cortical thickening has been observed.No metallosis detected.The surgeon revised the tibial tray, extension stem and liner.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/14MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10349985
• Report Number: 3005180920-2020-00475
• Device Sequence Number: 14219218
• Product Code: JWH
• UDI-Device Identifier: 07630030817298
• UDI-Public: 07630030817298
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2020

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: No Information
• Device Expiration Date: 11/01/2021
• Device Model Number: 02.07.0314SCF
• Device Catalogue Number: 02.07.1203R
• Device Lot Number: 167426
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/31/2020
• 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: 64 YR