MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC FEMORAL STEMS; MASTERLOC CEMENTLESS MECTAGRIP STEM LAT SIZE8

Model Number	01.39.208
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 nov 2025.Lot 168824: (b)(4) items manufactured and released on 05 may 2017.Expiration date: 12 april 2022.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with a similar reported events during the period of review.Root cause: 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
Revision surgery after 7 years and 8 months post-primary surgery due to stem loosening.The surgeon revised the stem and head.The surgery was completed successfully.

• Brand Name: MASTERLOC FEMORAL STEMS
• Common Device Name: MASTERLOC CEMENTLESS MECTAGRIP STEM LAT SIZE8
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23669505
• Report Number: 3005180920-2025-01196
• Device Sequence Number: 9699721
• Product Code: LZO
• UDI-Device Identifier: 07630030885686
• UDI-Public: 07630030885686
• Combination Product (Y/N): N
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/28/2025

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: 04/12/2022
• Device Model Number: 01.39.208
• Device Lot Number: 168824
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2017
• 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: Male