MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R; KNEE CEMENTED FEMORAL COMPONENT

Catalog Number	02.12.0005R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At 3 years from the primary, the patient came in due to signs of infection and the pathogen is unknown.The infection casued the loosening of the implants.The surgeon performed a washout and revised the femoral component, tibial tray and insert.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 24 novemeber 2023 lot 1909473: 92 items manufactured and released on 03-mar-2020.Expiration date: 2025-02-18.No anomalies found related to the problem.To date, 91 items of the same lot have been sold with no similar reported event during the period of review.Additional involved implants batch review performed on 24 novemeber 2023 on gmk-sphere 02.12.0410fr tibial insert fixed sphere flex size4/10 mm r (k121416) lot.2000442 lot 2000442: (b)(4) items manufactured and released on 19-feb-2020.Expiration date: 2025-02-05.No anomalies found related to the problem.To date, all items of the same lot have been sold with another similar reported event during the period of review.Batch review performed on 24 novemeber 2023 on gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot.1908635 lot 1908635: (b)(4) items manufactured and released on 25-marc-2020.Expiration date: 2025-03-16.No anomalies found related to the problem.To date, all items of the same lot have been sold with no other similar reported event during the period of review.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT
• 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: 18324594
• Report Number: 3005180920-2023-00993
• Device Sequence Number: 7358344
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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): 12/14/2023

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: 02/18/2025
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 1909473
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2020
• 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 Sex: Male
• Patient Race: White