MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; KNEE TIBIAL TRAY

Model Number	02.07.1205R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 october 2024: lot 1907844: (b)(4) items manufactured and released on 15-jan-2020.Expiration date: 2025-01-07.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Additional components involved and revised: batch review performed on 22 october 2024: gmk-sphere 02.12.0005r femoral component sphere cemented size 5 r (k121416) lot 1901850: (b)(4) items manufactured and released on 22-may-2019.Expiration date: 2024-05-13.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 22 october 2024: gmk-sphere 02.12.0512fr tibial insert fixed sphere flex size 5/12 mm r (k121416) lot 1908816: (b)(4) items manufactured and released on 14-nov-2019.Expiration date: 2024-11-02.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.Infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
Revision surgery at about 1 year and 4 months post primary due to infection, the pathogen is unknown.The surgeon revised all medacta hardware and reimplanted permanent product.The surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: KNEE TIBIAL TRAY
• 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: 20684039
• Report Number: 3005180920-2024-00944
• Device Sequence Number: 15261349
• Product Code: JWH
• UDI-Device Identifier: 07630030819933
• UDI-Public: 07630030819933
• 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: 2020
• 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): 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 Expiration Date: 01/15/2020
• Device Model Number: 02.07.1205R
• Device Lot Number: 1907844
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2020
• 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: 73 YR
• Patient Sex: Male
• Patient Race: White