MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; AMISTEM-P COLLARED LAT. SIZE0

Model Number	01.18.440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 june 2026 stem: amistem-p collared 01.18.440 amistem-p collared lat.Size 0 (k173794) lot 2520365: (b)(4) items manufactured and released on 26-feb-2026.Expiration date: 08-feb-2031.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.Root cause: based on the information available, no definitive root cause can be established.The absence of x-rays and further clinical details does not allow a more precise conclusion.The device history record review did not indicate any potentially related manufacturing issue, and there is no indication that a device-related issue may have caused or contributed to the event.
Event or Problem Description
At about 1 week from the primary, the patient came in presenting pain due to a fractured femur and the cause is unknown.There were no indications of trauma.The surgeon revised the medacta stem and head with competitor devices and replaced the double mobility liner with a liner of the same size.The surgery was completed successfully.

• Brand Name: AMISTEM-P COLLARED
• Common Device Name: AMISTEM-P COLLARED LAT. SIZE0
• 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: 25714736
• Report Number: 3005180920-2026-00622
• Device Sequence Number: 14738007
• Product Code: LZO
• UDI-Device Identifier: 07630040720298
• UDI-Public: 07630040720298
• Combination Product (Y/N): N
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 07/06/2026

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: 01.18.440
• Device Lot Number: 2520365
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2026
• 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: Unknown