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

Model Number	02.12.0005R
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager.Revision in tka 2 years after primary for joint instability.The surgeon decided to revise the implant with a more constrained knee design.The developmental instability is a rather commonly described possible complication following tka, because soft tissue may stretch and provide insufficient stability.This is not a problem due to any implant defect or malfunction.Batch review performed on 30 august 2021: lot 172741: (b)(4) items manufactured and released on 13-sep-2017.Expiration date: 2022-aug-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.Other implant involved: gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot.177238.Lot 177238: (b)(4) items manufactured and released on 22-jan-2018.Expiration date: 2023-jan-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Note: the insert has also been revised but we have no information on this.
Event or Problem Description
The patient's knee was medially unstable.The surgeon decided to revised all the implants to a gmk hinge system 2 years and 1 month after primary.

• Brand Name: GMK-SPHERE 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, 6874 ; SZ 6874
• MDR Report Key: 12419961
• Report Number: 3005180920-2021-00702
• Device Sequence Number: 14384119
• 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: 2021
• 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): 09/03/2021

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: 08/29/2022
• Device Model Number: 02.12.0005R
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 172741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR