MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC FEMORAL STEMS; MASTERLOC CEMENTLESS MECTAGRIP STEM LAT SIZE 10

Model Number	01.39.210
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At 2 years and 5 months the patient came in reporting pain due to a loose stem.The surgeon revised the medacta stem and head with a competitor stem and head and revised the liner with a medacta liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 august 2025: lot 2108756: 33 items manufactured and released on 19-oct-2021.Expiration date: 04-oct-2026.No anomalies found related to the problem.To date, 27 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director: 2.5 years after primary cementless tha, the patient reports pain and the radiographic analysis shows a severly loosened stem.The bone appears damaged, even beyond the stem vicinities, which leads to suspect a systemic of more genralized problem, not limited to the mechanical interaction with the device.We haven't been givent he preoperative and postoperative xrays, which would be essential to understand the evolution of this problem, but we strongly suspect that a biologic reaction or illness stepped in and prevented the stem from finding a durable stability.As no infection has been mentioned in the report, we consider this as a case of idiopatic aseptic loosening, but more information is needed to come to a conclusion.Aseptic loosening is a possible literature-described adverse event after primary hip arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.

• Brand Name: MASTERLOC FEMORAL STEMS
• Common Device Name: MASTERLOC CEMENTLESS MECTAGRIP STEM LAT SIZE 10
• 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: 23014740
• Report Number: 3005180920-2025-00825
• Device Sequence Number: 18558288
• Product Code: LZO
• UDI-Device Identifier: 07630030885709
• UDI-Public: 07630030885709
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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 Expiration Date: 10/04/2026
• Device Model Number: 01.39.210
• Device Lot Number: 2108756
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2021
• 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