MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R

Model Number	02.12.0211FR
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed due to dissociation of the pe inlay from the tibial baseplate at about 4 months after the primary surgery.The patient came in reporting pain when flexing his knee.The patient's rehabilitation did not proceed as expected, causing unnecessary pain and discomfort for four months.The hospital stay was also prolonged, and the health impact on the patient has been significant.The surgeon revised the insert and the surgery was completed successfully.It appears that the insert may have dislocated posteriorly from the joint capsule.This suggests that the insert might not have been properly locked during the procedure.However, during the surgery, the surgeon heard the "click" sound indicating the insert was secured, and the surgeon confirmed that the anterior aspects of both the insert and tibial tray were perfectly aligned with no gaps.Therefore, there was no issue with the handling of the product itself.
Additional Manufacturer Narrative
Batch review performed on 19 november 2024: lot 2201027: (b)(4) items manufactured and released on 06-apr-2022.Expiration date: 2027-03-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Additional device involved gmk-sphere 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot.2349049: (b)(4) items manufactured and released on 09-apr-2024.Expiration date: 2029-03-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Visual inspection performed by medacta knee r&d project manager: revision surgery of a gmk sphere tibial insert due to dislocation.From visual inspection of the removed component sent back for investigation, dents and scratches can be seen on its distal surface.These were most likely caused when the insert, dislocated in the joint, was pressed onto the baseplate under the action of bodyload.In particular, on the bottom surface of the posterior snapping features, we can notice an incision with the negative shape of the perimetral contour of the baseplate.This could be an evidence that the insert has never been correctly engaged in the baseplate.Considering also that the patient felt pain starting from immediately after the surgery, we guess the insert has never been correctly assembled to the baseplate.The surgeon reports to have heard the 'click' of of the snapping mechanism, but this could have come from the anterior locking mechanism despite the insert was not properly engaged posteriorly.From visual inspection, there is no evidence that the event is related to a faulty device.Root cause: the root cause of the event is likely incomplete engagement of the inlay during the primary surgery.The investigation does not indicate a potential manufacturing related issue or systemic deficiency.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R
• 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: 20900792
• Report Number: 3005180920-2024-01009
• Device Sequence Number: 5004713
• Product Code: JWH
• UDI-Device Identifier: 07630030862540
• UDI-Public: 07630030862540
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 12/11/2024

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 Model Number: 02.12.0211FR
• Device Lot Number: 2201027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian