MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIX CEMENTED S.1L

Model Number	02.07.1201L
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 24 april 2026 gmk-sphere 02.07.1201l tibial tray fix cemented s.1l (k090988) lot 2345276: (b)(4) items manufactured and released on 11-mar-2024.Expiration date: 24-feb-2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0110fl gmk-sphere tibial insert - flex s1l - 10 mm (k121416) lot 2404038: (b)(4) items manufactured and released on 22-mar-2024.Expiration date: 10-mar-2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0111fl gmk-sphere tibial insert - flex s1l - 11 mm (k140826) lot 2349252: (b)(4) items manufactured and released on 26-feb-2024.Expiration date: 06-feb-2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk efficiency 77.11.1110 trial insert flex s1 - 10l lot 2205467: (b)(4) items manufactured and released on 20-apr-2022.Expiration date: 05-apr-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 during the period of review.The batch review was performed on the tray set, as it is not possible to conduct it on the specific component involved in the complaint, i.E.The trial insert flex s1 - 10l (lot mat37802), for which 300 units were purchased from onostampi srl.Root cause: although no root cause can be confirmed, it is most likely that the prolonged surgical time was related to difficulties encountered during the positioning and fixation of the insert onto the tray, requiring multiple attempts before successful assembly.The investigation does not indicate a potential manufacturing-related issue or systemic deficiency.
Event or Problem Description
The surgeon experienced difficulty inserting the efficiency 10 mm left insert into a size 1 left cemented tibial baseplate, requiring multiple attempts.The patient achieved full extension with a rom of 120°, with no tightness issues.Difficulty was also encountered when inserting the definitive 10 mm polyethylene insert, leading to damage to its posterior aspect after repeated attempts.An 11 mm insert was then tried, also with multiple attempts, and was ultimately forcefully impacted using a tibial impactor.The procedure time was extended by approximately 45 minutes.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIX CEMENTED S.1L
• 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: 25160337
• Report Number: 3005180920-2026-00415
• Device Sequence Number: 10642555
• Product Code: JWH
• UDI-Device Identifier: 07630030819841
• UDI-Public: 07630030819841
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.07.1201L
• Device Lot Number: 2345276
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2024
• 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: Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Race: White