MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; GMK-REVISION 02.07.0034RP PATELLA RESURFACING SIZE 2

Model Number	02.07.0034RP
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2017.On (b)(6) 2020 the patient came in reporting pain due to a loose femur that was caused from falling.The surgeon revised the femoral component and liner.The surgery was completed successfully.Presently, on (b)(6) 2024, the patient came in reporting instability and the cause is unknown.The real issue was the patella dislocating lateral and he was focused to address that.He cut the patella out and didn't put another patella in.The surgeon addressed the patella tracking issues with suture and tissue tightening and re-alignment and revised the liner with one of the same thickness.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 10 dec 2024: lot 164132: (b)(4) items manufactured and released on 06-oct-2016.Expiration date: 2021-09-22.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: GMK-REVISION 02.07.0034RP PATELLA RESURFACING SIZE 2
• 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: 20902528
• Report Number: 3005180920-2024-01032
• Device Sequence Number: 20096744
• Product Code: JWH
• UDI-Device Identifier: 07630030815751
• UDI-Public: 07630030815751
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• 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): 12/11/2024

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 Expiration Date: 09/22/2021
• Device Model Number: 02.07.0034RP
• Device Lot Number: 164132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2016
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 21 KG
• Patient Race: White