MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC 01.39.012 CEMENTLESS TI COATED STD STEM SIZE 12; HIP CEMENTLESS STEM

Model Number	01.39.012
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 april 2021: lot 175574: (b)(4) items manufactured and released on 20-mar-2018.Expiration date: 2023-03-07 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar events have been reported on this lot.Clinical evaluation performed by medacta medical affairs manager: intraoperative femoral fractures are known possible adverse events of total hip replacements, described and quantified in literature.They mainly depend on bone morphology and mechanical properties.In this case, there is no reason to suspect a malfunctioning device.
Event or Problem Description
Intraoperative spiral femur bone fracture occurred.The surgeon cabled the fracture and completed successfully the surgery.

• Brand Name: MASTERLOC 01.39.012 CEMENTLESS TI COATED STD STEM SIZE 12
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11804379
• Report Number: 3005180920-2021-00370
• Device Sequence Number: 14364041
• Product Code: LZO
• UDI-Device Identifier: 07630030885617
• UDI-Public: 07630030885617
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: 03/07/2023
• Device Model Number: 01.39.012
• Device Catalogue Number: 01.39.012
• Device Lot Number: 175574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/11/2021
• 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
• Patient Age: 58 YR