MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC 01.39.413 CEMENTLESS TI COATED LAT PLUS STEM SIZE 13; HIP STEM CEMENTLESS

Model Number	01.39.413
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 march 2022.Lot 1811871: (b)(4) items manufactured and released on 23-may-2019.Expiration date: 2024-may-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Clinical evaluation performed by medical affairs director: few weeks after primary cementless tha a periprosthetic fracture occurred.No specific traumatic event is reported.Periprosthetic fractures are a possible adverse event following tha, described in the instructions for use.The preparation of the femoral bone by rasping is per se traumatic and during the rehabilitation period it is possible that sudden movements, perhaps linked to physiotherapy, may induce inappropriate stresses to the bone.We see no reason to suspect a faulty device at the origin of this adverse event.
Event or Problem Description
The patient came in reporting pain due to a periprosthetic fracture and the cause is unknown.About 5 weeks after the primary surgery, the surgeon cabled the fracture and revised the stem, head, and liner.The surgery was completed successfully.Bone quality was good and it is very unlikely that the fracture occurred intra-op during the primary.

• Brand Name: STEM: MASTERLOC 01.39.413 CEMENTLESS TI COATED LAT PLUS STEM SIZE 13
• Common Device Name: HIP STEM CEMENTLESS
• 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: 14160014
• Report Number: 3005180920-2022-00263
• Device Sequence Number: 14164576
• Product Code: LZO
• UDI-Device Identifier: 07630040731423
• UDI-Public: 07630040731423
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191145
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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: 05/12/2024
• Device Model Number: 01.39.413
• Device Catalogue Number: 01.39.413
• Device Lot Number: 1811871
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2019
• 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