MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-P LAT STEM SIZE 2; HIP CEMENTLESS STEM

Catalog Number	01.12.142
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 january 2020: lot 178282: (b)(4) items manufactured and released on 20-mar-2018.Expiration date: 2023-03-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Clinical evaluation performed by medacta medical affairs director: periprosthetic femoral fracture taking place few days after primary cementless tha.The cause is reportedly not a traumatic event.It is conceivable that it is related to consequences of the femoral preparation or the physiothepic treatments, we do not have enough elements to determine.No indication that it may be related to a faulty device.
Event or Problem Description
The patient came in reporting pain due to a periprosthetic fracture which was caused from getting up after being in a seated position.The surgeon cabled the fracture and revised the stem and liner almost 1 month after primary.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-P LAT STEM SIZE 2
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9664318
• Report Number: 3005180920-2020-00031
• Device Sequence Number: 16833395
• Product Code: LZO
• UDI-Device Identifier: 07630040720540
• UDI-Public: 07630040720540
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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: 03/08/2023
• Device Catalogue Number: 01.12.142
• Device Lot Number: 178282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 02/04/2020
• 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
• Patient Age: 68 YR