MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 6 R; KNEE REVISION FEMORAL COMPONENT

Model Number	02.07.2406R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department.Almost 10 years after revision knee arthroplasty in an overweight patient, pain and patellar overload require an exchange to a more constrained device.It is very likely, from the information received, that the change is postulated because of disease progression rather than implant malfunction.Batch review performed on 24 october 2022: lot 113210: (b)(4) items manufactured and released on 13-oct-2011.Expiration date: 2016-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional components involved: gmk-revision 02.07.Fcl13065 extension stem - fluted ø 13 l 65 (k120790) lot 115703: (b)(4) items manufactured and released on 07-aug-2012.Expiration date: 2017-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Gmk-revision 02.07.16tw tibial wedge size 6/10mm (k1024379 lot.082568: (b)(4) items manufactured and released on 20-oct-2008.Expiration date: 2013-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Gmk-revision 02.07.1206r fixed tibial tray cemented size 6 r (k090988) lot 113397: (b)(4) items manufactured and released on 15-dec-2011.Expiration date: 2016-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Gmk-revision 02.07.0005 offset connector 5 mm (k102437) lot.120330: (b)(4) items manufactured and released on 28-mar-2012.Expiration date: 2017-02-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Gmk-revision 02.07.0610psf tibial insert ps fixed size 6/10mm (k090988) lot.114238: (b)(4) items manufactured and released on 10-feb-2012.Expiration date: 2016-12-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
Revision surgery performed due to pain and patellofemoral overload with chronic extension deficit.Gmk hinge was implanted successfully.Explants were implanted in a revision surgery in 2012, after unicondylar implantation in 2008.Inlay exchange and patellar resurfacing was performed in 2014.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 6 R
• Common Device Name: KNEE REVISION FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15665112
• Report Number: 3005180920-2022-00781
• Device Sequence Number: 17760005
• Product Code: JWH
• UDI-Device Identifier: 07630030821479
• UDI-Public: 07630030821479
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2022

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: 08/31/2016
• Device Model Number: 02.07.2406R
• Device Catalogue Number: 02.07.2406R
• Device Lot Number: 113210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White