MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED PS SIZE 2NARROW / LEFT; CEMENTED FEMORAL COMPONENT

Model Number	02.07.2212L
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 september 2021: lot 124216a: (b)(4) item manufactured and released on 17-apr-2018.Expiration date: 2023-apr-25.No anomalies found related to the problem.Lot 124216a derives from lot 124216: lot 124216: (b)(4) items manufactured and released on 27-dec-2012.Expiration date: 2017-nov-30.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.Clinical evaluation performed by medical affairs director.3 years after revision tka, the femoral component is deemed to have ben placed too posteriorly and a decision is made to remove all components and exchange them with different devices.This adverse event was not caused by defective devices.
Event or Problem Description
At 2 years and 11 months after the primary medacta surgery, all implants were revised (with competitor) because the femur component was positioned too posteriorly and the cause is unknown.The surgeon revised all implants to competitor implants and the surgery was completed successfully.The patient had a competitor implants implanted during the primary surgery and had medacta implants implanted to revise the competitor implants on (b)(6) 2018.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED PS SIZE 2NARROW / LEFT
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12717355
• Report Number: 3005180920-2021-00834
• Device Sequence Number: 13793872
• Product Code: JWH
• UDI-Device Identifier: 07630030820946
• UDI-Public: 07630030820946
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2021

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: 04/25/2023
• Device Model Number: 02.07.2212L
• Device Catalogue Number: 02.07.2212L
• Device Lot Number: 124216A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/29/2021
• 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