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

Model Number	02.12.0410CRL
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18-11-24: lot 2244437: (b)(4) items manufactured and released on 03-01-2023.Expiration date: 2027-12-11.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.Clinical evaluation performed by clinical affairs director: few weeks after primary cemented tka, an infection occurs and revision with extraction of the implanted components is required.At surgery, the surgeon found that the infection process had damaged the collateral ligaments and therefore he chose a constrained implant to replace the former one.No reason to suspect a faulty device at the origin of this event.Additional implants revised, batch review performed on 18-11-24: gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot 2346732: (b)(4) items manufactured and released on 09-04-2024.Expiration date: 2029-03-14.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.Gmk-sphere 02.12.0005l gmk-sphere femoral component cemented - 5l (k121416) lot 2401837: (b)(4) items manufactured and released on 15-02-2024.Expiration date: 2029-01-29.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
At about 2 months from primary the surgeon revised alla components due to an infection and subsequent instability.Hinge implants have been implanted and surgery was completed successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK SPHERE CR TIBIAL INSERT SIZE 4L 10MM
• 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: 20851310
• Report Number: 3005180920-2024-01005
• Device Sequence Number: 19772572
• Product Code: JWH
• UDI-Device Identifier: 07630040707473
• UDI-Public: 07630040707473
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/05/2024

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 Model Number: 02.12.0410CRL
• Device Lot Number: 2244437
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White