MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID SMS COLLARED SOLID STEM STD SIZE 10; HIP SMS SOLID STEM CEMENTLESS

Catalog Number 01.36.150

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Pain (1994)

Event Date 08/18/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 22-aug-2023.Lot: 2206143: (b)(4) items manufactured and released on 20-sept-2022.Expiration date: 2027-08-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

Event Description

At about 4 months from the primary, the patient came in reporting pain due to an undersized stem.The cause of the undersized stem is unknown.The surgeon revised the stem and head.The surgery was completed successfully.

• Brand Name: STEM: SMS SOLID SMS COLLARED SOLID STEM STD SIZE 10
• Type of Device: HIP SMS SOLID 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 giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17709129
• MDR Text Key: 322925212
• Report Number: 3005180920-2023-00698
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630345701770
• UDI-Public: 07630345701770
• 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: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.36.150
• Device Lot Number: 2206143
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2022
• 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 Age: 66 YR
• Patient Sex: Male