MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 L; CEMENTED FEMORAL PROSTHESIS

Model Number	02.12.0002L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 december 2020 lot 172726: 30 items manufactured and released on 3-oct-2017.Expiration date: 2022-09-19.No anomalies found related to the problem.To date, 27 items of the same lot have been already sold with no other similar reported event.Additional implant involved: gmk-sphere 02.07.1202l tibial tray fixed cemented size 2 l (k090988) lot.1903525 batch review performed on 14 december 2020 lot 1903525: 67 items manufactured and released on 4-oct-2019.Expiration date: 2024-09-24.No anomalies found related to the problem.To date, 63 items of the same lot have been already sold with no other similar reported event.
Event or Problem Description
The patient came in reporting knee pain after 5 months from the primary surgery.Post-op x-rays indicated that femoral component and tibial tray were loose.The reason for the loose components is unknown.The surgeon revised the femoral component, tibial tray and insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 L
• Common Device Name: CEMENTED FEMORAL PROSTHESIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11087672
• Report Number: 3005180920-2020-00960
• Device Sequence Number: 17090459
• Product Code: JWH
• UDI-Device Identifier: 07630030825798
• UDI-Public: 07630030825798
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2020

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: 09/19/2022
• Device Model Number: 02.12.0002L
• Device Catalogue Number: 02.12.0002L
• Device Lot Number: 172726
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/29/2020
• 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