MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION EXTENSION STEM - FLUTED Ø 15 L 105; KNEE EXTENSION STEM

Catalog Number	02.07.FCL15105
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: 3 years after tka the screw that secures the offset femoral stem to the articular component backed out and gave pain.Additional surgery was performed to remove the loose screw.During surgery the insert was also changed to a new one, as customary, although no problem with the inlay had been detected.The system should be able to work properly in absence of the loose screw.The cause for self-unscrewing of this particular screw is not known and is an extremely rare occurrence.According to report, a torque-limiting screwdriver was used at surgery so the possible causes of unscrewing are further reduced.No conclusion can be drawn as to the causes of this incident.Batch review performed on 18 january 2018: (b)(4).
Event or Problem Description
The patient came in complaining of pain 3 years after primary.The femoral extension stem screw had backed out.The surgeon retrieved the screw without replacing it.He also swapped the insert.The surgery was completed successfully.Dinamometric screwdriver (6nm) was used to screw it in during the primary surgery.

• Brand Name: GMK-REVISION EXTENSION STEM - FLUTED Ø 15 L 105
• Common Device Name: KNEE EXTENSION STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7204888
• Report Number: 3005180920-2017-00848
• Device Sequence Number: 1448012
• Product Code: JWH
• UDI-Device Identifier: 07630030823008
• UDI-Public: 07630030823008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2018

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: 12/31/2017
• Device Catalogue Number: 02.07.FCL15105
• Device Lot Number: 124314
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/19/2018
• 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: 63 YR