MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK; PATELLA RESURFACING SIZE 4 E-CROSS

Model Number	02.12.E004RP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At 1 year and 1 month from the primary, the patient came in reporting anterior knee pain and instability and the cause is unknown.The surgeon revised the patella and upsized the poly (from 12 to 17 mm).The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 23 oct 2024: lot 2242111: (b)(4) items manufactured and released on 02-jan-2023.Expiration date: 2027-11-23.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-spherika 02.12.E0512fr tibial insert fixed sphere flex size 5/12 mm r e-cross (k202022) lot 2245485: (b)(4) items manufactured and released on 10-febr-2023.Expiration date: 2028-01-25.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.

• Brand Name: GMK
• Common Device Name: PATELLA RESURFACING SIZE 4 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: 20680970
• Report Number: 3005180920-2024-00935
• Device Sequence Number: 7229778
• Product Code: JWH
• UDI-Device Identifier: 07630971261006
• UDI-Public: 07630971261006
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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.E004RP
• Device Lot Number: 2242111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2023
• 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: 54 YR
• Patient Sex: Male