MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM # 3; HIP STEM CEMENTLESS

Model Number	01.39.203
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2021.Lot 1902837: 25 items manufactured and released on 26-jul-2019.Expiration date: 2024-jul-15.No anomalies found related to the problem.To date, 21 items of the same lot have been sold without any similar reported event.
Event or Problem Description
1 year and 9 months after the primary surgery the patient came in reporting pain due to a subsided stem and the cause of the subsided stem is unknown.The surgeon revised the stem and head and the surgery was completed successfully.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM # 3
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12391682
• Report Number: 3005180920-2021-00688
• Device Sequence Number: 12033980
• Product Code: LZO
• UDI-Device Identifier: 07630030885631
• UDI-Public: 07630030885631
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 08/31/2021

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: 07/15/2024
• Device Model Number: 01.39.203
• Device Catalogue Number: 01.39.203
• Device Lot Number: 1902837
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention