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

Catalog Number	02.12.E001RP
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 7 months after primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.
Additional Manufacturer Narrative
Batch review performed on 11-jan-2024 lot 2012664: (b)(4) items manufactured and released on 13-jan-2021.Expiration date: 2025-12-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional components involved: batch review performed on 11-jan-2024 gmk-sphere 02.12.0004r femoral component sphere cemented size 4 r (k121416) lot 2244557: (b)(4) items manufactured and released on 14-feb-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 case during the period of review.Gmk-sphere 02.12.E0410fr tibial insert fixed sphere flex size 4/10 mm r e-cross (k202022) lot 2241318: (b)(4) items manufactured and released on 03-jan-2023.Expiration date: 2027-12-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of the review.Gmk-sphere 02.12.T3i4r tibial tray fixed cemented size t3-i4 r (k121416) lot 2300367: (b)(4) items manufactured and released on 02-may-2023.Expiration date: 2028-04-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 1 E-CROSS
• Common Device Name: KNEE PATELLA RESURFACING
• 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: 18612968
• Report Number: 3005180920-2024-00014
• Device Sequence Number: 14063756
• Product Code: JWH
• UDI-Device Identifier: 07630971260979
• UDI-Public: 07630971260979
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2024

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: 12/28/2025
• Device Catalogue Number: 02.12.E001RP
• Device Lot Number: 2012664
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2021
• 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: Female