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

Model Number	02.12.E001RP
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15-feb-2023.Lot 2219299: (b)(4) manufactured and released on 26-oct-2022.Expiration date: 2027-10-05.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
The day after the primary surgery, the patient was revised because of dislocated patella implant.The dislocation occurred during post-op, in extension phase when patient tried to walk.The surgeon revised insert and femoral component and the surgery was completed successfully.Insert and femur revised to switch to a revision system, patella implant not revised.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 1 E-CROSS
• Common Device Name: KNEE PATELLA IMPLANT
• 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: 16435235
• Report Number: 3005180920-2023-00138
• Device Sequence Number: 3199349
• 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: 2023
• Device Explanted Year: 2023
• 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): 02/24/2023

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 Model Number: 02.12.E001RP
• Device Catalogue Number: 02.12.E001RP
• Device Lot Number: 2219299
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2022
• 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