MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC 01.39.207 CEMENTLESS TI COATED LAT STEM SIZE 7; HIP CEMENTLESS TI COATED LAT STEM

Model Number	01.39.207
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.At 3 years and 1 month from primary the surgeon revised the stem and head with competitor components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 19 april 2022: lot 186937: (b)(4) items manufactured and released on 05-dec-2018.Expiration date: 2023-11-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: STEM: MASTERLOC 01.39.207 CEMENTLESS TI COATED LAT STEM SIZE 7
• Common Device Name: HIP CEMENTLESS TI COATED LAT STEM
• 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: 14397933
• Report Number: 3005180920-2022-00367
• Device Sequence Number: 5326075
• Product Code: LZO
• UDI-Device Identifier: 07630030885679
• UDI-Public: 07630030885679
• 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: 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): 05/13/2022

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: 11/22/2023
• Device Model Number: 01.39.207
• Device Catalogue Number: 01.39.207
• Device Lot Number: 186937
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2018
• 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: Male