MAUDE Adverse Event Report: MEDACTA SWITZERLAND GMK-SPHERE 02.12.0023L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L; KNEE FEMORAL COMPONENT CEMENTED

Model Number	02.12.0023L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28-sep-2022.Lot 2108354: (b)(4) items manufactured and released on 14-sep-2021.Expiration date: 2026-08-29.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 28-sep-2022.Gmk-sphere 02.07.1203l tibial tray fixed cemented size 3 l (k090988) lot 2104549: (b)(4) items manufactured and released on 02-aug-2021.Expiration date: 2026-07-20.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 02.12.0310fl tibial insert fixed sphere flex size 3/10 mm l (k121416) lot 2108881: (b)(4) items manufactured and released on 09-sep-2021.Expiration date: 2026-08-29.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.
Event or Problem Description
At about 5 months after the primary surgery, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised successfully all the components.

• Brand Name: GMK-SPHERE 02.12.0023L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA SWITZERLAND; gewerbestrasse 3; frauenfeld, switzerland 8500 ; SZ 8500
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15672129
• Report Number: 3005180920-2022-00782
• Device Sequence Number: 6462252
• Product Code: JWH
• UDI-Device Identifier: 07630030862373
• UDI-Public: 07630030862373
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 10/26/2022

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: 08/29/2026
• Device Model Number: 02.12.0023L
• Device Catalogue Number: 02.12.0023L
• Device Lot Number: 2108354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2021
• 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