MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 R; KNEE CEMENTED FEMUR

Model Number	02.12.0004R
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a severely valgus joint line.The attempt to correct the leg axis in a stable way with a higher inlay (10 to 20 mm) failed.The surgeon revised all components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023: lot 2207164: (b)(4) items manufactured and released on 23-june-2022.Expiration date: 2027-06-09.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 device involved: batch review performed on (b)(6) 2023.Gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot 2208465: (b)(4) items manufactured and released on 08-oct-2022.Expiration date: 2027-08-21.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.Investigation performed by meadacta knee r&d project manager: revision surgery after almost 2 months from primary implantation, due to instability of a gmk sphere implant.According to the surgeon's indication, the instability was caused by excessive residual valgus.According to the pictures of the explanted devices, both the femur and the tibial tray present cement on the fixation surfaces.Some dents and scratches can be observed on the liner close to the anterior 'snapping' features for fixation to the baseplate.Those were most likely caused during the attempt of removing the tibial insert from the tibial baseplate.No other elements considered relevant for the analysis can be noted.There is no evidence that a faulty device have caused the revision.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 R
• Common Device Name: KNEE CEMENTED FEMUR
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16417087
• Report Number: 3005180920-2023-00098
• Device Sequence Number: 3503997
• Product Code: JWH
• UDI-Device Identifier: 07630030825842
• UDI-Public: 07630030825842
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 02/22/2023

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: 02.12.0004R
• Device Catalogue Number: 02.12.0004R
• Device Lot Number: 2207164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2022
• 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