MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SMS STEM; SMS SOLID STEM LAT SIZE 13

Model Number	01.36.073
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22-07-2025.Stem: sms solid 01.36.073 sms solid stem lat size 13 (k181693) lot 1903494: (b)(4) items manufactured and released on 05-07-2019 expiration date: 2024-06-24.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.Clinical evaluation performed by clinical affairs department: revision surgery was performed approximately one year after the primary total hip arthroplasty (tha) due to stem loosening.The patient had reported pain and underwent radiological follow-up.The available x-ray images confirm stem mobilization, with radiolucent lines particularly evident around the shoulder of the stem.Aseptic loosening is a well-documented complication in the literature, often with multifactorial or unclear etiology.Even in this case, the precise cause of the failure remains difficult to determine based on the available information.Aseptic loosening is a possible literature-described adverse event after primary hip arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.
Event or Problem Description
At about 1 year and 2 months from primary, the patient came in reporting pain due to a loose stem and the cause is unknown.The surgeon revised the stem, head and liner.The surgery was completed successfully.

• Brand Name: SMS STEM
• Common Device Name: SMS SOLID STEM LAT SIZE 13
• 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: 22714426
• Report Number: 3005180920-2025-00730
• Device Sequence Number: 9393531
• Product Code: LZO
• UDI-Device Identifier: 07630030888854
• UDI-Public: 07630030888854
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 08/05/2025

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 Expiration Date: 06/24/2024
• Device Model Number: 01.36.073
• Device Lot Number: 1903494
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2019
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Race: White