MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION EXTENSION STEM - FLUTED Ø 18 L 65; KNEE IMPLANT: EXTENSION STEM FLUTED

Model Number	02.07.FCL18065
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Torque limiter not used in primary surgery.Batch review performed on 11 february 2019: lot 157236: (b)(4) items manufactured and released on 26-jan-2016.Expiration date: 2021-01-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs manager: two years and 2 months after revision surgery in a (b)(6) woman, the stem fixation screw got loose in the joint.It was immediately removed; insert and screw were exchanged.The cause for self-unscrewing of the insert screw is not known: one possibility is insufficient tightening torque but other unknown conditions may also play a role.Visual inspection performed by r&d product manager: revision surgery after 2 years from primary surgery for self unscrewing of the screw that secure the fixation of the extension stem to the femoral component the returned screw is found slightly damaged in its threaded shaft.Some of the threads look partially pressed.This could be most likely caused managing the screw with the instruments used to remove it from the joint.Self unscrewing of the stem screw was most likely due to a insufficient tightening torque applied during fixation.The usage of a torque limiting screwdriver, available in every revision instrument set, is mandatory to secure the fixation of the stem with the femoral component by the screw.The torque limiting screwdriver was not used during the surgery.This was the reason of an insufficient tightening torque.
Event or Problem Description
[femur extension stem unscrewing] about 2 years and 2 months after primary the surgeon revised the patient knee because the extension stem screw was loose.Liner and stem screw swap.The surgery was completed successfully.
Additional Manufacturer Narrative
The brand name , catalog number and lot number have been corrected after we realized that have been reported with error.

• Brand Name: GMK-REVISION EXTENSION STEM - FLUTED Ø 18 L 65
• Common Device Name: KNEE IMPLANT: EXTENSION STEM FLUTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8338970
• Report Number: 3005180920-2019-00052
• Device Sequence Number: 1954698
• Product Code: JWH
• UDI-Device Identifier: 07630030823053
• UDI-Public: 07630030823053
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K120790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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 Expiration Date: 01/16/2021
• Device Model Number: 02.07.FCL18065
• Device Catalogue Number: 02.07.FCL18065
• Device Lot Number: 157236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 02/26/2020
• 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: 67 YR