MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION 3DMETAL FEMORAL CONE SMALL TRIAL; INSTRUMENT FOR KNEE SURGERY

Catalog Number	02.07.10.4888
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 july 2020 lot 2051540: (b)(4) items manufactured and released on 11-may-2020.No anomalies found related to the problem.To date, any other similar event has been reported.Additional instrument involved: gmk hinge 02.09.10.0054 hinge trial femur #2 r lot.1551733 batch review performed on 20 july 2020.Lot 1551733: (b)(4) items manufactured and released on 25-jan-2010.Expiration date: 2014-12.No anomalies found related to the problem.To date, any similar event has been reported on this lot since 2016.
Event or Problem Description
During a revision surgery of a competitor knee to a medacta knee, the surgeon was starting to prep for the femoral cone,.While prepping for the femoral cone, the surgeon pulled the hinge femoral trial off and observed he had fractured the distal femoral condyle.The surgeon decided not to revise the patient with medacta products and instead revised with competitor products.It was also observed that the patient had very poor bone quality.There was a 1 hour and 45 minute delay in the case and additional anesthesia was necessary.The surgery was completed successfully.The fracture reason's is bone loss and bone quality.The point of fracture is medial femoral condyle.

• Brand Name: GMK-REVISION 3DMETAL FEMORAL CONE SMALL TRIAL
• Common Device Name: INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10343416
• Report Number: 3005180920-2020-00479
• Device Sequence Number: 10968994
• Product Code: LXH
• UDI-Device Identifier: 07630971268029
• UDI-Public: 07630971268029
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2020

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: Health Professional
• Device Catalogue Number: 02.07.10.4888
• Device Lot Number: 2051540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/30/2020
• 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: Other