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

Model Number	01.39.205
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 september 2020: lot 184010: (b)(4) items manufactured and released on 02-oct-2018.Expiration date: 2023-09-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in, 9 months after primary surgery, reporting pain due to a subsided stem.The cause of the subsided stem is unknown.The surgeon revised the head and liner and the surgery is completed successfully.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 5
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10572821
• Report Number: 3005180920-2020-00631
• Device Sequence Number: 1270314
• Product Code: LZO
• UDI-Device Identifier: 07630030885655
• UDI-Public: 07630030885655
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2020

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: 09/20/2023
• Device Model Number: 01.39.205
• Device Catalogue Number: 01.39.205
• Device Lot Number: 184010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/23/2020
• 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