MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 6; KNEE FEMORAL IMPLANT

Model Number	02.09.2606R
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 december 2020: lot 171440: (b)(4) items manufactured and released on 24-may-2017.Expiration date: 2022-05-01.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.
Event or Problem Description
The patient came in, 1 year and 3 months after primary surgery, reporting pain and instability.X-rays revealed a fractured cement mantle proximal to the femoral stem extension and loose femoral components.The cause of the fractured cement mantle and the loose femoral components is unknown.The surgeon revised the femoral component and the surgery was completed successfully.
Additional Manufacturer Narrative
Primary surgery date: (b)(6) 2017.Event description:the patient came in, 3 years and 3 months after primary surgery, reporting pain and instability.X-rays revealed a fractured cement mantle proximal to the femoral stem extension and loose femoral components.The cause of the fractured cement mantle and the loose femoral components is unknown.The surgeon revised the femoral component and the surgery was completed successfully.
Event or Problem Description
The patient came in, 3 years and 3 months after primary surgery, reporting pain and instability.X-rays revealed a fractured cement mantle proximal to the femoral stem extension and loose femoral components.The cause of the fractured cement mantle and the loose femoral components is unknown.The surgeon revised the femoral component and the surgery was completed successfully.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 6
• Common Device Name: KNEE FEMORAL IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11106981
• Report Number: 3005180920-2021-00013
• Device Sequence Number: 14351442
• Product Code: KRO
• UDI-Device Identifier: 07630030825507
• UDI-Public: 07630030825507
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: 05/01/2022
• Device Model Number: 02.09.2606R
• Device Catalogue Number: 02.09.2606R
• Device Lot Number: 171440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 03/12/2021
• 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