MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA RESURFACING SIZE 1 E-CROSS; PATELLA RESURFACING E-CROSS

Model Number	02.12.E001RP
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 september 2022.Lot 2012664: 65 items manufactured and released on 13-jan-2021.Expiration date: 2025-dec-28.No anomalies found related to the problem.To date, 52 items of the same lot have been sold with 1 similar reported event (same patient, previous revision surgery) during the period of review.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2022.On (b)(6) 2022, the patient came in reporting looseness after dislocating the patella.The surgeon revised the gmk-sphere tibial insert e-cross - flex 3l -10mm with a gmk-sphere tibial insert e-cross - flex 3l -14mm and repositioned the patella with soft tissue repair.The surgery was completed successfully.Presently, on (b)(6) 2022, the patient came in reporting looseness after dislocating the patella again.The surgeon decide to revise all components to hinge components.The surgery was completed successfully.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 1 E-CROSS
• Common Device Name: PATELLA RESURFACING E-CROSS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15579655
• Report Number: 3005180920-2022-00774
• Device Sequence Number: 6385964
• Product Code: JWH
• UDI-Device Identifier: 07630971260979
• UDI-Public: 07630971260979
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 10/11/2022

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: 12/28/2025
• Device Model Number: 02.12.E001RP
• Device Catalogue Number: 02.12.E001RP
• Device Lot Number: 2012664
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2021
• 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