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

Model Number	01.39.209
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on december 3, 2021: lot 2003025: (b)(4).Expiration date: 2025-jul-20.No anomalies found related to the problem.(b)(4).
Event or Problem Description
The patient came in for a post-op appointment and it was observed that the patient's femur fractured below the lower distal tip of the stem.It is unknown how this occurred.Two weeks after the primary surgery, the surgeon cabled the fracture and revised the stem, head, and liner.The surgery was completed successfully.Patient had weak bone.On the original primary surgery we utilized the straight stem impactor along with the standard broaches with the direct anterior broach handles.We are not sure when the fracture happened.It is a possibility that the fracture occurred during the primary hip replacement.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 9
• Common Device Name: CEMENTLESS STEM
• 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: 13025505
• Report Number: 3005180920-2021-01012
• Device Sequence Number: 11236244
• Product Code: LZO
• UDI-Device Identifier: 07630030885693
• UDI-Public: 07630030885693
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2021

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: 07/20/2025
• Device Model Number: 01.39.209
• Device Catalogue Number: 01.39.209
• Device Lot Number: 2003025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2020
• 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 Sex: Unknown