MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM L; KNEE TIBIAL INSERT

Model Number	02.12.0513FL
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 march 2023: lot 2115185: 50 items manufactured and released on 12-jan-2022.Expiration date: 2026-dec-19.No anomalies found related to the problem.To date, 28 items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 5 april 2023 gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot 2001511: 155 items manufactured and released on 27-apr-2020.Expiration date: 2025-apr-14.No anomalies found related to the problem.To date, 152 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2020.On (b)(6) 2023, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in reporting pain after falling directly on the knee, which caused the poly to disengage from the baseplate.The surgeon revised the poly and the surgery was completed successfully.During the primary surgery, the rep didn't hear a click sound at liner coupling with the tibial base and wasn't sure if the doctor heard a click sound.The surgeon said it looked like the liner was in, but its possible it wasn't in posteriorly.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.Revision surgery of a gmk sphere implant after almost 2 years from primary implantation due to pain occurred after a fall of the patient.During the revision surgery, the uhmwpe was found disengaged from the baseplate.From visual inspection of the explanted component sent back for investigation, the insert looks damaged in its bottom surface, intended to be engaged with the baseplate, presenting dents and scratches and plastic deformations.Those were most likely caused when the insert was disengaged, interposed between the femoral component and the baseplate and leaning on the peripheral edge of the baseplate and subjected to body load.We guess that the insert was not properly engaged in the baseplate already at the time of the primary surgery.The fall could have then played a role in the complete disengagement of the inlay causing pain and damage.From visual inspection, there is no evidence to suspect that the event is related to a faulty device.Note: follow-up reported in delay due to human error.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM L
• Common Device Name: KNEE TIBIAL INSERT
• 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: 16687667
• Report Number: 3005180920-2023-00213
• Device Sequence Number: 7396954
• Product Code: JWH
• UDI-Device Identifier: 07630030862656
• UDI-Public: 07630030862656
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 06/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.12.0513FL
• Device Catalogue Number: 02.12.0513FL
• Device Lot Number: 2115185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male