MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-C 01.12.044 CEMENTED, MIRROR POLISHING STD STEM SIZE 4 12/14; FEMORAL COMPONENT

Model Number	01.12.044
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06.12.2021: lot 179263: (b)(4) items manufactured and released on 28-mar-2018.Expiration date: 2023-03-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event.Preliminary analysis performed by r&d manager: looking at the images attached to the complaint it is visible that the stem body is completely covered with cement bone.Only the proximal part of the stem close to the resection line is free of bone cement.It is not possible to determine to root cause of reported stem mobilization and explant.
Event or Problem Description
Revision surgery was performed 2 years and 3 months after the primary surgery due to stem mobilization.The patient isn´t a sporty person.Uses crutches for years, puts little strain on the leg.

• Brand Name: QUADRA-C 01.12.044 CEMENTED, MIRROR POLISHING STD STEM SIZE 4 12/14
• Common Device Name: 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: 13078028
• Report Number: 3005180920-2021-00999
• Device Sequence Number: 12169796
• Product Code: LZO
• UDI-Device Identifier: 07630030802256
• UDI-Public: 07630030802256
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083558
• 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): 12/23/2021

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: 03/20/2023
• Device Model Number: 01.12.044
• Device Catalogue Number: 01.12.044
• Device Lot Number: 179263
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2018
• 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 Sex: Unknown