MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 8; HIP STEM CEMENTLESS

Model Number 01.39.208

Device Problem Malposition of Device (2616)

Patient Problem Implant Pain (4561)

Event Date 02/21/2023

Event Type  Injury  

Event Description

At about 5 years 1 month after the primary, the patient came in reporting pain due to an unstable hip.There was anteversion of the stem.The surgeon revised the medacta stem and head with competitor components and revised the medacta liner with a medacta liner.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 21 march 2023.Lot 168824: (b)(4) items manufactured and released on 05-may-2017.Expiration date: 2022-04-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 8
• Type of Device: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco ; strada regina
• MDR Report Key: 16583376
• MDR Text Key: 311684034
• Report Number: 3005180920-2023-00181
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030885686
• UDI-Public: 07630030885686
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2022
• Device Model Number: 01.39.208
• Device Catalogue Number: 01.39.208
• Device Lot Number: 168824
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male