MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L; KNEE FEMORAL COMPONENT

Catalog Number	02.12.0003L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 march 2024: lot 171000: (b)(4) items manufactured and released on 27-jun-2017.Expiration date: 2022-06-07.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 medacta medical affairs director: 7 years after primary tka with a medially stabilized device in an elderly lady, the knee grew instable and a semi-constrained device was required, most probably for loss of strength in the collateral ligaments.The original components had not mobilized but a system with more intrinsic stability was required.This revision is not due to the failure of the former treatment, rather to disease progression.Additional implant involved, batch review performed on 13 march 2024: gmk-sphere 02.12.0212fl tibial insert fixed sphere flex size 2/12 mm l (k121416) lot 166328: (b)(4) items manufactured and released on 05-dec-2016.Expiration date: 2021-11-15.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.
Event or Problem Description
Revision for knee laxity at 6 years and 4 months post primary.Femur and liner revised, gmk revision implanted successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L
• 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: 19070211
• Report Number: 3005180920-2024-00174
• Device Sequence Number: 6994603
• Product Code: JWH
• UDI-Device Identifier: 07630030825811
• UDI-Public: 07630030825811
• 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 Implanted Year: 2017
• 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): 04/09/2024

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: 06/07/2022
• Device Catalogue Number: 02.12.0003L
• Device Lot Number: 171000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2017
• 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: 84 YR
• Patient Sex: Female