MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SMS STEM; SMS COLLARED SOLID STEM LAT SIZE5

Model Number	01.36.165
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the patient had primary left hip surgery using a medacta head and stem.A competitor's liner was used.On 20 (b)(6) 2025, the patient came in due to an infection and the pathogen is unknown.The surgeon revised the medacta head with a medacta head and revised the competitor liner with a competitor liner.The surgery was completed successfully.Presently, on (b)(6) 2025, the patient came in due to infection and the cause is unknown.The surgeon revised the medacta head and stem with a medacta head and stem.The surgeon revised the competitor liner with a competitor liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 31 october 2025.Stem: sms solid collared 01.36.165 sms collared solid stem lat size 5 (k203041) lot 2349433: (b)(4) 2025 items manufactured and released on 07-may-2024.Expiration date: 21-apr-2029.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.Ball heads: mectacer 01.29.214 mectacer head biolox delta dia.40 12/14-l (k112115) lot 2304163: (b)(4) items manufactured and released on 17-mar-2023.Expiration date: 23-feb-2028.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: SMS STEM
• Common Device Name: SMS COLLARED SOLID STEM LAT SIZE5
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23579960
• Report Number: 3005180920-2025-01142
• Device Sequence Number: 21181673
• Product Code: LZO
• UDI-Device Identifier: 07630345701879
• UDI-Public: 07630345701879
• Combination Product (Y/N): N
• PMA/510(K) Number: K203041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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 Model Number: 01.36.165
• Device Lot Number: 2349433
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2024
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Race: White