MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM L

Model Number	02.12.0410CRL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 april 2021 lot 188577: (b)(4) items manufactured and released on 30-jan-2019.Expiration date: 2024-01-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director: few days after primary cemented tka infection is suspected and the patient is brought back to operating room, where the knee is lavaged.The insert is replaced and it is found severely damaged, after only a few days.According to report, the femoral component was not damaged.Only the massive presence of third bodies in the articulation (invisible on the xray) could have done such damage, but there is no mention of them in the report.The event cannot be fully understood and we have no idea of the real cause for reoperation.The suspected infection was not confirmed.Visual inspection performed by r&d project manager: revision surgery after 10 days from primary of a gmk sphere implant due to infection.During revision surgery, knee joint was washed out and the tibial insert was replaced.Articular surface of the tibial insert looks abnormally damaged with scratches and small craters.This was most likely due to the presence of a third body.From visual inspection there is no evidence that the event is related to a faulty device.
Event or Problem Description
Revision surgery following liner wear 2 weeks after primary.During surgery it was noticed that the femoral component did not show any damage, only the inlay was worn on both sides.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11752485
• Report Number: 3005180920-2021-00346
• Device Sequence Number: 3439075
• Product Code: JWH
• UDI-Device Identifier: 07630040707473
• UDI-Public: 07630040707473
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 04/30/2021

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 Expiration Date: 01/13/2024
• Device Model Number: 02.12.0410CRL
• Device Catalogue Number: 02.12.0410CRL
• Device Lot Number: 188577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR