MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L; KNEE FEMORAL COMPONENT CEMENTED

Model Number	02.12.0023L
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At 8 months after the primary surgery the patient came in reporting instability and hyperextension and the cause is unknown.The surgeon revised the femoral component and insert.The surgeon used a thicker liner to provide greater varus/valgus stability and revised the femoral component to give the patient a post to reduce hyperextension.
Additional Manufacturer Narrative
Batch review performed on 01 december 2021.Lot 2008776: (b)(4) items manufactured and released on 27-oct-2020.Expiration date: 2025-oct-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional component involved: gmk-sphere 02.12.0210crl tibial insert fixed sphere cr size 2/10 mm l (k181635) lot.2007486 lot 2007486: (b)(4) items manufactured and released on 16-sep- 2020.Expiration date: 2025-aug-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• 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: 13042814
• Report Number: 3005180920-2021-01003
• Device Sequence Number: 5409903
• Product Code: JWH
• UDI-Device Identifier: 07630030862373
• UDI-Public: 07630030862373
• 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: 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): 12/20/2021

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: 10/14/2025
• Device Model Number: 02.12.0023L
• Device Catalogue Number: 02.12.0023L
• Device Lot Number: 2008776
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2020
• 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