MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #5/13 MM L; KNEE TIBIAL INSERT

Model Number	02.12.0513FL
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 july 2021.Lot 151945: (b)(4) items manufactured and released on 7-july-2015.Expiration date: 2020-may-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event since 2017.Other components involved: gmk-sphere 02.12.0005l femoral component sphere cemented # 5 l lot.186106 k121416.Lot 186106: (b)(4) items manufactured and released on 15-nov-2018.Expiration date: 2023-oct-25.No anomalies found related to the problem.To date, all items of the same lot have been sold without a similar reported event.Gmk-sphere 02.07.1205l tibial tray fixed cemented # 5 l lot.186201 k090988.Lot 186201: (b)(4) items manufactured and released on 12-nov-2018.Expiration date: 2023-oct-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.
Event or Problem Description
2 years and 2 months after the primary surgery the patient came in reporting pain and instability and the cause of both the pain and instability is unknown.The surgeon decided to give the patient a full revision and revise the femur, tibia, and insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #5/13 MM L
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12353121
• Report Number: 3005180920-2021-00674
• Device Sequence Number: 19826919
• Product Code: JWH
• UDI-Device Identifier: 07630030862656
• UDI-Public: 07630030862656
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2021

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: 05/31/2020
• Device Model Number: 02.12.0513FL
• Device Catalogue Number: 02.12.0513FL
• Device Lot Number: 151945
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/23/2021
• 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