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

Model Number	01.39.212
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 september 2021: lot 162136: (b)(4) items manufactured and released on 31-may-2016.Expiration date: 2021-05-22.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 since 2017.
Event or Problem Description
The patient had a primary total left hip surgery on (b)(6) 2019.The patient dislocated post-operatively, and on (b)(6) 2019, the surgeon revised the stem, head, and liner.Presently, on (b)(6) 2021, 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 with competitor implants.The surgery was completed successfully.

• Brand Name: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 12
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12432606
• Report Number: 3005180920-2021-00711
• Device Sequence Number: 3308737
• Product Code: LZO
• UDI-Device Identifier: 07630030885723
• UDI-Public: 07630030885723
• 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: 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): 09/07/2021

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: 05/22/2021
• Device Model Number: 01.39.212
• Device Catalogue Number: 01.39.212
• Device Lot Number: 162136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/07/2021
• 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