MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC 01.39.207 CEMENTLESS TI COATED LAT STEM SIZE 7; HIP STEM

Catalog Number	01.39.207
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
About 8 months after the primary surgery, the patient complained of thigh pain.There was no sign of infection but the x-rays showed signs of stem loosening.During the revision, the stem was perfectly fixed, so the surgeon placed a sleeve and revised the head.
Additional Manufacturer Narrative
Batch review performed on 11 june 2024.Lot 2108753: (b)(4) manufactured and released on 11-oct-2021.Expiration date: 2026-sep-28.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: STEM: MASTERLOC 01.39.207 CEMENTLESS TI COATED LAT STEM SIZE 7
• Common Device Name: HIP 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: 19711156
• Report Number: 3005180920-2024-00480
• Device Sequence Number: 8541349
• Product Code: LZO
• UDI-Device Identifier: 07630030885679
• UDI-Public: 07630030885679
• 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: 2024
• 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): 07/10/2024

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: 09/28/2026
• Device Catalogue Number: 01.39.207
• Device Lot Number: 2108753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2021
• 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: Female