MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; PATELLA RESURFACING S.3 (NEW GENERATION)

Model Number	02.07.0035RP
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 march 2026.Gmk-sphere 02.07.0035rp patella resurfacing s.3 (new generation) (k090988) lot 2111896: (b)(4) items manufactured and released on 10-nov-2021.Expiration date: 27-oct-2026.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event since the batch release.Gmk-sphere 02.12.E0510crl gmk-sphere tibial insert e-cross - cr 5l - 10mm (k202022) lot 2212154: (b)(4) items manufactured and released on 06-sep-2022.Expiration date: 16-aug-2027.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event since the batch release.Root cause: the surgeon revised liner height, which is a common practice to restore the joint stability.Aseptic loosening is a possible literature-described adverse event after primary joint 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.
Event or Problem Description
At about 1 year and 6 months from the primary, the patient came in presenting instability due to a loose patella and the cause is unknown.No trauma was reported.The surgeon revised the medacta patella to a competitor patella and revised the gmk-sphere size 5l -10mm insert to a gmk-sphere size 5l -12mm insert.The surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: PATELLA RESURFACING S.3 (NEW GENERATION)
• 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: 24558227
• Report Number: 3005180920-2026-00222
• Device Sequence Number: 8932749
• Product Code: JWH
• UDI-Device Identifier: 07630030815768
• UDI-Public: 07630030815768
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/10/2026

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 Model Number: 02.07.0035RP
• Device Lot Number: 2111896
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Race: White