MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID 01.36.045 SMS SOLID STEM STD SIZE 5; HIP SOLID STEM

Model Number 01.36.045

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 12/30/2022

Event Type  Injury  

Event Description

The patient came in reporting pain due to a subsided stem 3 months after the primary.The surgeon revised the head with a longer head.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 03-january-2023.Lot 2114510: (b)(4) items manufactured and released on 09-mar-2022.Expiration date: 27-feb-2027.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: SMS SOLID 01.36.045 SMS SOLID STEM STD SIZE 5
• Type of Device: HIP SOLID STEM
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16253519
• MDR Text Key: 308258492
• Report Number: 3005180920-2023-00004
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030888649
• UDI-Public: 07630030888649
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181693
• 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: 01/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 01.36.045
• Device Catalogue Number: 01.36.045
• Device Lot Number: 2114510
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2022
• 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: Female