MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION TRIAL OFFSET 3MM; REUSABLE INSTRUMENT FOR KNEE SURGERIES

Catalog Number	02.07.10.8651
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 november 2023.Lot 2257626: (b)(4) items manufactured and released on 03-jan-2023.No anomalies found related to the problem.To date, another similar event has been reported on the same lot.Clinical evaluation performed by medical affairs director: during a tka revision procedure, the trial components disassembled when hammered upwards to remove them from the tibial bone.An elastic clip gave way and the lower part of the trial component, along with the intramedullary stem, remained in the tibial bone.When trying to withdraw the locked components using a second trial offset, the same problem happened again, and the surgeon decided to open the tibial bone and manually free the locked components.Apparently, the stem-offset assembly got stuck in the tibia canal and when hammered to be retrieved, it disassembled.We cannot judge if the locking of the stem in the canal was due to exceptional circumstances, such as, for instance, a particularly narrow or warped canal, excessive press-fit, or orientation defect.The causes of the lock-up cannot be determined with the information at hand.The tibia was then closed with cerclage and final implants were positioned and cemented.There is no specific clinical cause for the adverse event, which resulted in lengthening of the operation time and hopefully no further complications, if the cabled bone can heal successfully and sustain the implants.Analysis performed by r&d manager: the performed analysis confirmed that the antirotational insert of the trial offset has been disassembled from the main body during trial removal from the bone.During extraction of the system consisting of extension stem, trial offset and trial keel assembly from the bone, the elastic clipping of the threaded insert of the trial offset is unable to withstand the blows and disengages from the offset body itself.
Event or Problem Description
The anti-rotational insert of the trial offset 3mm broke during the removal of the trial assembly.To remove the trial stem from the intramedullary canal, the surgeon tried to engage it with a second trial offset (5 mm) but it broke as well.The surgeon had to open the tibial bone up to the apex and then perform a tibial cerclage.There was 1 hour and a half of delay in the surgery due to this event.Total surgery time: about 3 hours.
Additional Manufacturer Narrative
Corrected data: on (b)(6), 2024, fda informed us that the incorrect product code had been entered in the emdr form.

• Brand Name: GMK-REVISION TRIAL OFFSET 3MM
• Common Device Name: REUSABLE INSTRUMENT FOR KNEE SURGERIES
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18256291
• Report Number: 3005180920-2023-00923
• Device Sequence Number: 5805242
• Product Code: LXH
• UDI-Device Identifier: 07630345713148
• UDI-Public: 07630345713148
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02.07.10.8651
• Device Lot Number: 2257626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White