MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L; KNEE TIBIAL INSERT

Catalog Number	02.12.0311FL
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 march 2024 lot 2305659: (b)(4) items manufactured and released on 13-apr-2023.Expiration date: 2028-mar-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional component involved: gmk-sphere 02.07.1203l tibial tray fixed cemented size 3 l (k0909889) lot 2318059: (b)(4) items manufactured and released on 13-oct-2023.Expiration date: 2028-sep-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Visual inspection performed by r&d project manager.Revision surgery after one month from primary surgery due to tibial insert dislocation of a gmk sphere implant.From visual inspection of the removed component, the insert looks damaged in its distal surface in contact with the tibial baseplate.It presents a sort of incisions of the negative shape of the tibial baseplate; these have been most likely caused by the edges of the lateral profile of the baseplate when the insert underwent body load pressure and was not engaged in the tibial tray.Looking also at the post-primary x-rays, we can notice that the insert was likely already disengaged from the baseplate right after the surgery (and so probably never engaged).In fact, the distance between the femoral component and the tibial baseplate seems too high to represent the thickness of the insert if properly engaged into the baseplate.There is no reason to suspect that the event was caused by a faulty device.Clinical evaluation performed by medical affairs department.Partial revision surgery a few weeks after primary cemented tka.The reason for the revision was insert dissociation from the baseplate.In fact, from the postoperative radiograph, it appears that the insert was already dislocated at that time, and therefore it's legitimate to hypothesize that it never got fully clipped in.The insert is mechanically damaged by improper loading; therefore, an exhaustive dimensional check cannot be performed with conclusive results.We do not think that a plausible root cause for this event can be sought in the clinical performance of the implant.
Event or Problem Description
Revision surgery performed due to dissociation of the inlay from the tibial baseplate 1 month after the primary surgery.The inlay has been revised.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 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: 18957292
• Report Number: 3005180920-2024-00062
• Device Sequence Number: 21173252
• Product Code: JWH
• UDI-Device Identifier: 07630030862564
• UDI-Public: 07630030862564
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2024

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 Catalogue Number: 02.12.0311FL
• Device Lot Number: 2305659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian