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

Model Number	02.12.0005R
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2022.Subsequently, the patient had signs of infection and the pathogen was unknown.On (b)(6) 2022, the surgeon performed a washout and swapped the poly.On (b)(6) 2024, the had pain, due to a deficient mcl and a dislocation of the patella implant.The knee was infected.The surgeon explanted the patellar implant, revised the femoral component and poly and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 26 nov 2024: lot 2116065: (b)(4) items manufactured and released on 24-jan-2022.Expiration date: 2027-01-10.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional devices revised: batch reviews performed on 26 nov 2024: gmk-sphere 02.07.0034rp patella resurfacing size 2 (k090988) lot 2202656: (b)(4) items manufactured and released on 11-may-2022.Expiration date: 2027-04-21.No anomalies found related to the problems.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0410fr tibial insert fixed sphere flex size 4/10 mm r (k121416) lot 2201058: (b)(4) items manufactured and released on 24-mar-2022.Expiration date: 2027-03-01.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.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
• 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: 20900786
• Report Number: 3005180920-2024-01049
• Device Sequence Number: 5004710
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/11/2024

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: 02.12.0005R
• Device Lot Number: 2116065
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2022
• 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: Unknown