MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 3 L

Model Number	02.07.2403L
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 24 july 2020: lot 1900618: (b)(4) items manufactured and released on 23-05-2019.Expiration date: 2024-05-13, no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Other device involved in the event: gmk-revision 02.07.10.0858 trial tibial insert sc fixed #2 - 10 mm lot.1410625.Batch review performed by medacta regulatory affairs department on 24 july 2020: lot 1410625: (b)(4) items manufactured and released on 05-06-2014.No anomalies found related to the problem.To date, no other similar events have been reported since 2016.
Event or Problem Description
During the primary knee surgery, while the surgeon was trialing the sc trial insert with the final femoral and tibial implants, the trial insert would not lock into the final tibial baseplate.During this trial range of motion a fracture of the medial distal femoral condyle was noticed.The surgeon cabled the fracture to stabilize the components.The surgery was completed successfully.The surgeon was able to insert the final implant poly insert into the baseplate.The fracture may have developed when impacting the femoral implant component.Further, the bone was of very poor quality and was deficient in much of the distal femur.We also used a femoral cone augment to try to reinforce the distal femur which required further removal of some remaining cancellous distal bone.The medial distal femoral condyle didn't partially displace however until we were doing a trial range of motion with the trial insert paired with the final implant femoral and tibial components.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 3 L
• Common Device Name: FEMUR REVISION
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10366570
• Report Number: 3005180920-2020-00511
• Device Sequence Number: 2345178
• Product Code: JWH
• UDI-Device Identifier: 07630030821400
• UDI-Public: 07630030821400
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• 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): 08/05/2020

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: 05/13/2024
• Device Model Number: 02.07.2403L
• Device Catalogue Number: 02.07.2403L
• Device Lot Number: 1900618
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/05/2020
• 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