MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 12; HIP STEM CEMENTLESS

Model Number	01.39.212
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At 9 months and 9 days after the primary, the patient came in reporting pain due to a subsided stem and the cause of the subsided stem is unknown.The surgeon tried to remove the stem but it was pretty well fixed so he revised the liner and fixed the leg length discrepancy by changing the head size.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 18 january 2022.Lot 1904521: (b)(4) items manufactured and released on 10-oct-2019.Expiration date: 2024-09-25.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold without any similar reported event.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 12
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13469423
• Report Number: 3005180920-2022-00084
• Device Sequence Number: 3886952
• Product Code: LZO
• UDI-Device Identifier: 07630030885723
• UDI-Public: 07630030885723
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 02/07/2022

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: 09/25/2024
• Device Model Number: 01.39.212
• Device Catalogue Number: 01.39.212
• Device Lot Number: 1904521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2019
• 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 Sex: Unknown