MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-C 01.12.042 CEMENTED, MIRROR POLISHING STD STEM SIZE 2 12/14; HIP STEM CEMENTED

Model Number	01.12.042
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 9 november 2022: lot 2006159: (b)(4) items manufactured and released on 22-sep-2020.Expiration date: 2025-sep-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
The patient presented with a periprosthetic femoral fracture about 1 month after the primary surgery.The surgeon replaced the stem and head with non-medacta implants but left the cup and liner in situ.He could not confirm what caused the fracture or when the fracture occurred.

• Brand Name: STEM: QUADRA-C 01.12.042 CEMENTED, MIRROR POLISHING STD STEM SIZE 2 12/14
• Common Device Name: HIP STEM CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15869293
• Report Number: 3005180920-2022-00895
• Device Sequence Number: 5486181
• Product Code: LZO
• UDI-Device Identifier: 07630030802232
• UDI-Public: 07630030802232
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 11/28/2022

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: 09/10/2025
• Device Model Number: 01.12.042
• Device Catalogue Number: 01.12.042
• Device Lot Number: 2006159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2020
• 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 Age: 84 YR
• Patient Sex: Female