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

Model Number	01.39.405
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 april 2021: lot 174262: (b)(4) items manufactured and released on 18-oct-2017.Expiration date: 2022-10-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot.181299.Batch review performed on 07 april 2021: lot 181299: (b)(4) items manufactured and released on 10-july-2018.Expiration date: 2023-06-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
2 years 5 months after the primary the patient came in reporting left thigh pain and the cause of the pain is unknown.The surgeon successfully revised the stem and head.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS 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: 11751437
• Report Number: 3005180920-2021-00344
• Device Sequence Number: 19692686
• Product Code: LZO
• UDI-Device Identifier: 07630040715775
• UDI-Public: 07630040715775
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 04/30/2021

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: 10/05/2022
• Device Model Number: 01.39.405
• Device Catalogue Number: 01.39.405
• Device Lot Number: 174262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/30/2021
• 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
• Patient Age: 68 YR