MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L; CEMENTED FEMORAL COMPONENT

Model Number	02.07.2004L
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 april 2022: lot 103136: (b)(4) items manufactured and released on 08-nov-2010.Expiration date: 2015-09-30.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event since 1-jan-2018.Additional implant involved: gmk-primary 02.07.0412fuc tibial insert uc fixed size 4 / 12 mm (k090988) lot.091786.Batch review performed on 25 april 2022: lot 091786: (b)(4) items manufactured and released on 07-aug-2009.Expiration date: 2014-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 1-jan-2018.
Event or Problem Description
The patient came in reporting pain and the cause is unknown.At 11 years and 5 months post primary the surgeon revised the femur and poly.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14427349
• Report Number: 3005180920-2022-00379
• Device Sequence Number: 20449572
• Product Code: JWH
• UDI-Device Identifier: 07630030820212
• UDI-Public: 07630030820212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• 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): 05/17/2022

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: 09/30/2015
• Device Model Number: 02.07.2004L
• Device Catalogue Number: 02.07.2004L
• Device Lot Number: 103136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2010
• 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 Sex: Male