MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID STEM LAT SIZE 11; HIP SMS SOLID STEM CEMENTLESS

Model Number	01.36.071
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023: lot 2112230: (b)(4) items manufactured and released on 07-gen-2022.Expiration date: 2026-12-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs department: revision 5 months after the primary surgery due to a stem loosening.The patient came in reporting pain due to a loose and subsided stem and the cause is unknown.Only one radiographic projection was supplied, which makes it very difficult to assess if the stem was slightly undersized.Undersizing is one of the most common causes of early implant subsidence and it may well degenerate into final loosening.However, other possible causes may have contributed to this early loosening, but we cannot determine them with the information at hand.
Event or Problem Description
The patient came in reporting pain due to a loose and subsided stem and the cause is unknown.The loosening happened before the subsidence.At about 5 months post primary the surgeon revised the stem and head and the surgery was completed successfully.

• Brand Name: STEM: SMS SOLID STEM LAT SIZE 11
• Common Device Name: 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: 16813624
• Report Number: 3005180920-2023-00295
• Device Sequence Number: 5733847
• Product Code: LZO
• UDI-Device Identifier: 07630030888830
• UDI-Public: 07630030888830
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2023

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: 01.36.071
• Device Catalogue Number: 01.36.071
• Device Lot Number: 2112230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2022
• 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 Sex: Male