MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID 01.36.070 SMS SOLID STEM LAT SIZE 10; HIP SMS SOLID STEM

Model Number 01.36.070

Device Problem No Apparent Adverse Event (3189)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/16/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 31-may-2023 lot 2116621: (b)(4) items manufactured and released on 22-apr-2022.Expiration date: 2027-04-10.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

During the surgery, the implant subsided and the post-op ct scans showed a bone fracture.No revision surgery has been planned and the surgeon is monitoring the patient.

• Brand Name: STEM: SMS SOLID 01.36.070 SMS SOLID STEM LAT SIZE 10
• Type of Device: HIP SMS 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17144077
• MDR Text Key: 317456484
• Report Number: 3005180920-2023-00447
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030888823
• UDI-Public: 07630030888823
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/16/2023

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: 01.36.070
• Device Catalogue Number: 01.36.070
• Device Lot Number: 2116621
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2022
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian