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

Model Number	02.12.0022R
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18.November.2021: lot 2003247: (b)(4) items manufactured and released on 15-07-2020.Expiration date: 2025-07-06.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been sold without other similar reported events.Additional implant involved: gmk-sphere 02.12.0217fr tibial insert fixed sphere flex size 2/17 mm r (k121416) lot.173800.Batch review performed on 18.November.2021: lot 173800: (b)(4) items manufactured and released on 28-07-2017.Expiration date: 2022-07-16.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been sold without other similar reported events.
Event or Problem Description
At 10 months after the primary surgery, the patient came in reporting instability due to loose ligaments the cause of the loose ligaments is unknown.The surgeon revised the femoral component and insert.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R
• Common Device Name: CEMENTED FEMORAL COMPONENT
• 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: 12974187
• Report Number: 3005180920-2021-00973
• Device Sequence Number: 4291646
• Product Code: JWH
• UDI-Device Identifier: 07630030862366
• UDI-Public: 07630030862366
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/10/2021

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: 07/06/2025
• Device Model Number: 02.12.0022R
• Device Catalogue Number: 02.12.0022R
• Device Lot Number: 2003247
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2020
• 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: Female