MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SMS COLLARED SOLID STEM STD SIZE 6; HIP STEM

Catalog Number 01.36.146

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Implant Pain (4561)

Event Date 09/19/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2023.Lot 2206139: (b)(4) items manufactured and released on 28-sep-2022.Expiration date: 2027-09-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

Event Description

At about 6 months after the primary, the patient came in reporting pain due to a subsided stem and the cause is unknown.The surgeon revised successfully the medacta stem and head with competitor implants and revised the medacta liner with a medacta liner.

• Brand Name: SMS COLLARED SOLID STEM STD SIZE 6
• Type of Device: HIP 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17918134
• MDR Text Key: 325444764
• Report Number: 3005180920-2023-00788
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630345701732
• UDI-Public: 07630345701732
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203041
• 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: 10/12/2023

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 Catalogue Number: 01.36.146
• Device Lot Number: 2206139
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2022
• 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