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
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2023-00447
• Device Sequence Number: 13930171
• Product Code: LZO
• UDI-Device Identifier: 07630030888823
• UDI-Public: 07630030888823
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 01.36.070
• Device Catalogue Number: 01.36.070
• Device Lot Number: 2116621
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian