MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION EXTENSION STEM - FLUTED 18 L 105

Model Number	02.07.FCL18105
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 february 2021: lot 186598: (b)(4) items manufactured and released on 15-oct-2018.Expiration date: 2023-10-03.No anomalies found related to reported problems.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 director: at follow up visit, a loose screw is noted in the posterior part of the joint, clinically irrelevant so far, but it is not apparent if this screw came out of the implanted prosthesis.In fact, this would be possible, though rather unlikely, if this screw was the stem fixation screw.Its self-unscrewing is an extremely rare occurrence.
Event or Problem Description
Through the x-rays the surgeon recognized a screw unscrewed 1 year and 1 month after the last surgery.Probably the screw comes from the femoral extention stem, the entire construct is composed of augments, stems and offsets.No revision surgery is planned at the moment.For all screws, it was confirmed that the correct torque limiter, where necessary, was used.

• Brand Name: GMK-REVISION EXTENSION STEM - FLUTED 18 L 105
• Common Device Name: EXTENSION STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11307400
• Report Number: 3005180920-2021-00096
• Device Sequence Number: 3374496
• Product Code: JWH
• UDI-Device Identifier: 07630030823060
• UDI-Public: 07630030823060
• 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: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

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: 03/10/2023
• Device Model Number: 02.07.FCL18105
• Device Catalogue Number: 02.07.FCL18105
• Device Lot Number: 186598
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 02/10/2021
• 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