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

Model Number	02.12.E001RP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 7 months after the primary surgery, the patient came in reporting pain, and the cause was unknown.The surgeon revised the patella to a thinner patella and removed more bone.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 22 july 2025: gmk-spherika 02.12.E001rp gmk-sphere resurfacing patella e-cross - s1 (k202022) lot.2400498: (b)(4) items manufactured and released on 21-dec-2020.Expiration date: 01-dec-2025.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Conclusions: the surgeon opted for a thinner patella and additional bone resection due to unknown clinical factors, likely related to intraoperative bone stock assessment during the primary surgery.No device-related anomalies were identified.The root cause is therefore considered patient-specific and not device-related.

• Brand Name: GMK
• Common Device Name: PATELLA RESURFACING SIZE 1 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22577498
• Report Number: 3005180920-2025-00725
• Device Sequence Number: 21278320
• 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: 2024
• Device Explanted Year: 2025
• 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): 07/23/2025

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: 12/01/2025
• Device Model Number: 02.12.E001RP
• Device Lot Number: 2400498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2020
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White