MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM

Model Number	02.07.0312PSF
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 november 2020 lot 189208: 30 items manufactured and released on 01-mar-2019.Expiration date: 2024-02-11.No anomalies found related to the problem.To date, 21 items of the same lot have been already sold without any other similar reported event.Additional item involved in the event: gmk-primary 02.07.1203r tibial tray fixed cemented size 3 r (k090988) lot.1907834.Batch review performed on 09 november 2020.Lot 1907834: 127 items manufactured and released on 08-jan-2020.Expiration date: 2024-12-15.No anomalies found related to the problem.To date, 116 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting an inability to achieve full flexion.The surgeon cut more proximal tibia and revised the gmk tibial tray cemented right s3 with a rev.Tibial tray right s2, and revised the insert p.S.12mm s3 with a insert p.S.17mm s2 and added an extension stem 7 months after primary.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM
• Common Device Name: TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10910301
• Report Number: 3005180920-2020-00836
• Device Sequence Number: 3045593
• Product Code: JWH
• UDI-Device Identifier: 07630030817168
• UDI-Public: 07630030817168
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2020

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: 02/11/2024
• Device Model Number: 02.07.0312PSF
• Device Catalogue Number: 02.07.0312PSF
• Device Lot Number: 189208
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/26/2020
• 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