MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC FEMORAL STEMS; HIP CEMENTLESS TI COATED STEM

Model Number	01.39.211
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: a revision surgery was performed approximately 9 months after the primary implantation of a tha due to stem subsidence.Despite the lack of post-operative x-rays, the available images clearly show the stem subsidence.Determining the root cause of this failure is challenging with the current information.Potential factors may include undersizing of the stem, improper initial positioning or poor bone quality.No definitive conclusions can be drawn.Batch review performed on 23 october 2024 lot 1902845: 20 items manufactured and released on 04-july-2019.Expiration date: 2024-06-30.No anomalies found related to the problem.To date, 18 items of the same lot have been sold with no similar reported events during the period of review.This issue may have been caused by the undersizing of the stem and/or patient specific factors, but the precise circumstances cannot be confirmed.Although no definitive root cause can be confirmed, there is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
Revision surgery due to masterloc stem subsidence, at about 9 months from the primary.The surgeon implanted an amis-k with a ceramic head.The cup not revised.

• Brand Name: MASTERLOC FEMORAL STEMS
• Common Device Name: HIP CEMENTLESS TI COATED 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: 20620132
• Report Number: 3005180920-2024-00938
• Device Sequence Number: 12645857
• Product Code: LZO
• UDI-Device Identifier: 07630030885716
• UDI-Public: 07630030885716
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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 Expiration Date: 06/30/2024
• Device Model Number: 01.39.211
• Device Lot Number: 1902845
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2019
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White