MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R; KNEE FEMORAL IMPLANT

Model Number	02.12.0005R
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	04/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain and swelling.The surgeon decided to revise the patient and discovered that all implants were loose and did not bond with the cement.The cause of this is unknown.At 1 year and 11 months after the primary surgery, the surgeon revised all implants and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 13 april 2022: lot 1905069: 80 items manufactured and released on 04-oct-2019.Expiration date: 2024-sep-23.No anomalies found related to the problem.To date, 73 items of the same lot have been sold with no similar reported event.Additional devices involved batch reviews performed on 13 april 2022: gmk-sphere 02.07.1205r tibial tray fixed cemented # 5 r lot.1908382 (k090988): lot 1908382: 77 items manufactured and released on11-feb-2020.Expiration date: 2025-feb-01.No anomalies found related to the problem.To date, 75 items of the same lot have been sold with no similar reported event.Gmk-sphere 02.07.0035rp patella resurfacing size 3 lot.1908306 (k090988): lot 1908306: 240 items manufactured and released on 07-nov-2019.Expiration date: 2024-oct-15.No anomalies found related to the problem.To date, 236 items of the same lot have been sold with no similar reported event.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
• Common Device Name: KNEE FEMORAL IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14346313
• Report Number: 3005180920-2022-00351
• Device Sequence Number: 5270114
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• 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: 2022
• 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): 05/10/2022

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: 09/23/2024
• Device Model Number: 02.12.0005R
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 1905069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male