MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ R; KNEE FEMORAL COMPONENT

Catalog Number	02.12.0021R
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 may 2024.Lot 2310663: (b)(4) items manufactured and released on 26-july-2023.Expiration date: 2028-07-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional component involved: gmk-sphere 02.12.0214fr tibial insert fixed sphere flex size 2/14 mm r (k121416) lot.2002781: (b)(4) items manufactured and released on 20-may-2020.Expiration date: 2025-05-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
Revision surgery due to knee luxation, at about 1 month after primary.Femoral component, insert, and tibial tray successfully revised.Exact primary surgery date is unknown.
Additional Manufacturer Narrative
On 12 june 2024 we have received the tibial component (gmk-sphere 02.07.1202r tibial tray fixed cemented size 2 r) and the insert (gmk-sphere 02.12.0214fr tibial insert fixed sphere flex size 2/14 mm r lot.2002781).The femoral component was not available for inspection.Visual inspection performed by r&d project manager: revision surgery of a gmk sphere implant after 1 month from primary surgery due to luxation of the femur on the tibia occurred after a fall of the patient.From visual inspection of the explanted tibial baseplate and insert, any anomalies can't be detected.We guess the event is related to the traumatic event of the falling or to an improper balancing of the knee during the primary surgery.From visual inspection, there is no evidence that the event is related to a faulty device.
Event or Problem Description
Revision surgery due to knee luxation (femoral component from the liner), at about 1 month after primary.The patient had a domestic incident and during rehabilitation the femoral component dislocated.The surgeon revised all components to hinge components.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ R
• Common Device Name: KNEE FEMORAL COMPONENT
• 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: 19371341
• Report Number: 3005180920-2024-00364
• Device Sequence Number: 7703245
• Product Code: JWH
• UDI-Device Identifier: 07630030862458
• UDI-Public: 07630030862458
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 07/01/2024

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 Catalogue Number: 02.12.0021R
• Device Lot Number: 2310663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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: 77 YR
• Patient Sex: Unknown
• Patient Race: White