MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; RESURFACING PATELLA SIZE 4

Model Number	02.07.0036RP
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Implant Pain (4561); Aseptic loosening (4883)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery after 4 years and 7 months due to a loose patella implant, and the cause is unknown.There are no indications of trauma.The surgeon observed that the patella was still in place but loose and easily removed.The surgeon revised the patella resurfacing s4 to a moto patella e-cross d 35 and revised the 12mm flex6l tibial insert to a 10mm flex6l tibial insert at his discretion.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 24 june 2026 02.07.0036rp resurfacing patella size 4 (k113571) lot.2106040: (b)(4) manufactured and released on 03 august 2021.Expiration date: 15 july 2026.No anomalies related to the issue were reported.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Root cause:aseptic loosening is a possible literature-described adverse event after primary hip arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: RESURFACING PATELLA SIZE 4
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25663302
• Report Number: 3005180920-2026-00606
• Device Sequence Number: 12161633
• Product Code: JWH
• UDI-Device Identifier: 07630030815775
• UDI-Public: 07630030815775
• Combination Product (Y/N): N
• PMA/510(K) Number: K113571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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: 07/15/2026
• Device Model Number: 02.07.0036RP
• Device Lot Number: 2106040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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: Male