MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; AMISTEM-P COLLARED LAT. SIZE1

Model Number	01.18.441
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	06/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 july 2026 amistem-p collared 01.18.441 amistem-p collared lat.Size 1 (k173794) lot 2238600: (b)(4) items manufactured and released on 02 february 2023.Expiration date: 10 january 2028.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold, with no similar reported events during the period of review.Mpact 01.32.146dht acetabular shell d 46 two-holes t (k230011) lot 2418545: (b)(4) items manufactured and released on 07 november 2024.Expiration date: 22 october 2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold, with no similar reported events during the period of review.Root cause:based on the information available, the revision surgery was performed due to a reported titanium allergy, with no alleged device deficiency involved.The device history record review does not indicate any potentially related manufacturing issue.
Event or Problem Description
Revision surgery due to titanium allergy after about 9 months after primary.The surgeon removed all existing implants, cemented a hooded pe hc liner d 36/e and quadra-p cemented lat.Size 1 and revised the 32mm biolox delta head s to a 36mm biolox delta head m.The patient had a fracture so the titanium cables were replaced with mbrace cables.The surgery was completed successfully.

• Brand Name: AMISTEM-P COLLARED
• Common Device Name: AMISTEM-P COLLARED LAT. SIZE1
• 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: 25763497
• Report Number: 3005180920-2026-00658
• Device Sequence Number: 9787525
• Product Code: LZO
• UDI-Device Identifier: 07630040720304
• UDI-Public: 07630040720304
• Combination Product (Y/N): N
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 07/09/2026

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: 01.18.441
• Device Lot Number: 2238600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• 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: 60 YR
• Patient Sex: Female
• Patient Race: White