MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

Model Number	02.12.0410FL
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to infection and loosening.Primary surgery date unknown.
Additional Manufacturer Narrative
Batch review performed on 25 november 2024: lot 2102534: (b)(4) items manufactured and released on 21-apr-2021.Expiration date: 2026-04-08.No anomalies found related to the problem.To date, all items of the same lot have been sold with one similar reported event during the period of review.Additional devices involved batch review performed on 25 november 2024: gmk-sphere 02.12.0025l femoral component sphere cemented size 5+ l (k140826) lot 1907932: (b)(4) items manufactured and released on 20-nov-2019.Expiration date: 2024-11-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot 2103804: (b)(4) items manufactured and released on 12-may-2021.Expiration date: 2026-04-26.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Root cause: 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.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L
• 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: 20832758
• Report Number: 3005180920-2024-01002
• Device Sequence Number: 3863236
• Product Code: JWH
• UDI-Device Identifier: 07630030826535
• UDI-Public: 07630030826535
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

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: 04/08/2026
• Device Model Number: 02.12.0410FL
• Device Lot Number: 2102534
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2021
• 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 Age: 60 YR
• Patient Sex: Unknown