MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 9; HIP CEMENTLESS STEM

Catalog Number	01.39.209
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During the primary hip surgery on (b)(6) 2024, it was observed that the patient had sustained an intra-op fracture.The surgeon cabled the fracture around the proximal part and the surgery was completed successfully.On (b)(6) 2024, the surgeon noticed that the fracture was below the proximal part.Since the surgeon did not cable distally during the primary, he decided to revise the patient.The stem and head were substituted and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 26 january 2024: lot 2244892: (b)(4) items manufactured and released on 12-apr-2023.Expiration date: 2028-03-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 9
• Common Device Name: HIP CEMENTLESS STEM
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18657246
• Report Number: 3005180920-2024-00042
• Device Sequence Number: 12815149
• Product Code: LZO
• UDI-Device Identifier: 07630030885693
• UDI-Public: 07630030885693
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 02/07/2024

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 Catalogue Number: 01.39.209
• Device Lot Number: 2244892
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Race: White