MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC LATPLUS; STEM: MASTERLOC 01.39.412 CEMENTLESS TI COATED LAT PLUS STEM SIZE 12

Model Number	01.39.412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28-01-2025.Lot 2304305: (b)(4) items manufactured and released on 26/07/2023.Expiration date: 2028/07/05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation: a periprosthetic fracture was detected immediately after tha surgery during a postoperative x-ray while the patient was recovering in the pacu.It remains unclear whether the fracture occurred intraoperatively during the closing phase of the surgery or in the immediate postoperative period.Additionally, there is no reported evidence of a traumatic event.The available x-ray clearly confirms a spiral femoral fracture involving the entire stem.Standard femoral preparation during surgery may have weakened the bone, predisposing it to an early fracture.Furthermore, the patient's bone quality could have played a role in this event.However, there is insufficient information to draw a definitive conclusion regarding the root cause of the failure.The surgeon revised liner height, which is a common practice to restore the joint stability.There is no indication that any potential issue with the device may have caused or contributed to the event.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
On the same day of the primary, while the patient was in the pacu, x-rays were taken that showed a fracture.The surgeon cabled the fracture and revised the medacta head and stem to competitor devices.Liner and cup were kept.The surgery was completed successfully.

• Brand Name: MASTERLOC LATPLUS
• Common Device Name: STEM: MASTERLOC 01.39.412 CEMENTLESS TI COATED LAT PLUS STEM SIZE 12
• 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: 21432760
• Report Number: 3005180920-2025-00027
• Device Sequence Number: 11897425
• Product Code: LZO
• UDI-Device Identifier: 07630040715843
• UDI-Public: 07630040715843
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 02/21/2025

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 Model Number: 01.39.412
• Device Lot Number: 2304305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male