MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0005R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R; KNEE FEMORAL COMPONENT CEMENTED

Catalog Number	02.12.0005R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06-oct-2023 lot 178716: (b)(4) items manufactured and released on 07-feb-2018.Expiration date: 2023-01-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation "performed" by medical affairs director: 4 years after primary cemented tka, a revision is performed.No information was supplied.From the pre-revision xrays, a terminal damage to the collateral ligaments seem to have taken place, possibly because of trauma, and of course a constrained device was then called for.Without additional information, no further comment can be offered, but we see no clue towards a defect in the implanted device or its performances.Other devices involved: gmk-sphere 02.12.0410fr tibial insert fixed sphere flex size 4/10 mm r (k121416) lot 1901315: (b)(4) items manufactured and released on 13-may-2019.Expiration date: 2024-04-27.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot 1901601: (b)(4) items manufactured and released on 05-jun-2019.Expiration date: 2024-05-25.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 4 years and 1 month after primary, the patient has been revised because of instability.All the components have been revised with competitor components.

• Brand Name: GMK-SPHERE 02.12.0005R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• 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: 17886293
• Report Number: 3005180920-2023-00780
• Device Sequence Number: 7289563
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• 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: 2019
• 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): 10/06/2023

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 Expiration Date: 01/25/2023
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 178716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2018
• 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: 50 YR
• Patient Sex: Unknown