MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L; KNEE TIBIAL INSERT

Catalog Number	02.12.0413FL
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
At about 5 years from the primary, during a follow-up visit, it was noted from the x-rays that the inlay locking screw was loose in the posterolateral aspect of the knee.About 7 years after the primary surgery, a second follow-up showed that the screw has not moved.At this time, an additional/revision surgery is not planned, the patient does not feel any pain and has a full range of movement.
Additional Manufacturer Narrative
Batch review performed on 21 november 2023.Lot 143217: 50 items manufactured and released on 26-sept-2014.Expiration date: 2019-08-31.No anomalies found related to the problem.To date, 33 the items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs department in 2016, primary tka is performed on a relatively young patient.A screw is used to secure the insert to the tibial baseplate.3 years later, the screw is still in place, but looking with attention at the xray it appears that it may have started a process of self-unscrewing.In 2021, at 5 years, the screw has backed out completely and is now loose in the vicinities of the joint, but definitely far away from the articular surfaces.Now, after 7 years, it's still there.The surgeons decided that the position of the screw is not dangerous for the patient and left it there.The patient is advised and monitored, but there is no clinical anomaly and none should be expected.The most likely cause of this event is insufficient tightening torque during the primary surgery.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 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: 18274789
• Report Number: 3005180920-2023-00967
• Device Sequence Number: 14247144
• Product Code: JWH
• UDI-Device Identifier: 07630030862618
• UDI-Public: 07630030862618
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 02.12.0413FL
• Device Lot Number: 143217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2014
• 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: Other
• Patient Age: 63 YR
• Patient Sex: Female