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

Model Number	01.26.45.0056
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 29 september 2020: lot 185591: (b)(4) items manufactured and released on 16-oct-2018.Expiration date: 2023-09-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery performed 11 months after the primary surgery due to loose knee (instability).The surgeon revised the gmk sphere cr tibial insert s4l 13mm with a gmk-sphere tibial insert - flex s4l - 14mm.The surgery was completed successfully.The agent said that the patient did not have loose implants, it was the knee itself that felt loose.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED CR SIZE 4/13 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: 10689826
• Report Number: 3005180920-2020-00713
• Device Sequence Number: 3899590
• Product Code: JWH
• UDI-Device Identifier: 07630030807794
• UDI-Public: 07630030807794
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• 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): 10/16/2020

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: 09/27/2023
• Device Model Number: 01.26.45.0056
• Device Catalogue Number: 02.12.0413CRL
• Device Lot Number: 185591
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/16/2020
• 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