MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED CR SIZE 2/12 MM R; KNEE TIBIAL INSERT

Model Number	02.12.0212CRR
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 january 2021: lot 185611: (b)(4) items manufactured and released on 25-sep-2018.Expiration date: 2023-09-10.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 additional device involved: batch review performed on 13 january 2021: gmk-sphere 02.12.0022r femoral component sphere cemented size 2+ r (k140826) lot 162678: (b)(4) items manufactured and released on 19-may-2016.Expiration date: 2021-05-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar events have been reported since 2017.
Event or Problem Description
The patient came in reporting pain and swelling in the knee 7 months after the primary.Infection excluded, the cause of the pain and swelling is unknown.The surgeon revised the femoral component and insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED CR SIZE 2/12 MM R
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11271429
• Report Number: 3005180920-2021-00083
• Device Sequence Number: 3842780
• Product Code: JWH
• UDI-Device Identifier: 07630040707244
• UDI-Public: 07630040707244
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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: 09/10/2023
• Device Model Number: 02.12.0212CRR
• Device Catalogue Number: 02.12.0212CRR
• Device Lot Number: 185611
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 02/03/2021
• 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