MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 5; HIP CEMENTLESS STEM

Model Number	01.39.005
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 december 2022: lot 1907485: (b)(4) items manufactured and released on 11-feb-2020.Expiration date: 2025-jan-26.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 performed by medacta medical affairs manager: stem revision performed almost 5 months after primary cementless total hip arthroplasty in a bilateral operated patient. the patient came in reporting pain due to a loose stem (left) and the cause of the loose stem is unknown.The surgeon revised the medacta stem and head with competitor components and the surgery was completed successfully.According to report, there was no traumatic event or signs of infection.In the radiographic image provided, no signs of stress shielding are visible.The fixation device visible in the radiograph was probably implanted before primary hip surgery.It is rather unusual that the stem could be implanted without removal of the osteosynthesis material.This may have caused an undersized stem to give the impression of sufficient stability, then failing to achieve satisfactory long term fixation.
Event or Problem Description
The patient is a bilateral patient.The patient came in reporting pain due to a loose stem (left) and the cause of the loose stem is unknown.About 5 months after the primary surgery, the surgeon revised the medacta stem and head with competitor components and the surgery was completed successfully.There was no traumatic event or signs of infection, scans showed some movement with no known cause.The implant had ingrowth and fixation upon removal.

• Brand Name: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 5
• Common Device Name: HIP CEMENTLESS 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16136876
• Report Number: 3005180920-2022-00998
• Device Sequence Number: 12441833
• Product Code: LZO
• UDI-Device Identifier: 07630030885549
• UDI-Public: 07630030885549
• 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: 2022
• Device Explanted Year: 2022
• 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): 01/11/2023

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: 01/26/2025
• Device Model Number: 01.39.005
• Device Catalogue Number: 01.39.005
• Device Lot Number: 1907485
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2020
• 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