MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; AMISTEM-P COLLARED STD. SIZE4

Model Number	01.18.434
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to infection after about 1 month from primary surgery.The surgeon performed a washout and revised the amistem-p size4 to an amistem-p size5, revised the d 28/dmh liner to a d 28/dmi liner, revised the 28mm biolox head s to a same size head, and revised the mpact dm d 56 cup to a mpact dm d 58 cup.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 05 june 2026 amistem-p collared 01.18.434 amistem-p collared std.Size4 (k173794) lot.2511598: (b)(4) items manufactured and released on (b)(6) 2025.Expiration date: 2030-aug-18.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 dm 01.26.2856mhc double mobility hc liner d 28/dmh (k092265) lot.2243170: (b)(4) items manufactured and released on 03-jan-2023.Expiration date: 2027-dec-04.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.Mectacer 01.29.201 mectacer head biolox delta dia.28 12/14-s (k112115) lot.2422196: (b)(4) items manufactured and released on 02-sep-2024.Expiration date: 2029-jul-28.No anomalies found related to the problem.To date, 96 items of the same lot have been sold with no similar reported events during the period of review.Mpact 01.32.156mb mpact dm acetabular shell d 56 (k143453) lot.2416955: (b)(4) items manufactured and released on 19-dec-2024.Expiration date: 2029-dec-03.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: 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: AMISTEM-P COLLARED
• Common Device Name: AMISTEM-P COLLARED STD. SIZE4
• 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: 25442544
• Report Number: 3005180920-2026-00563
• Device Sequence Number: 5727574
• Product Code: LZO
• UDI-Device Identifier: 07630040720236
• UDI-Public: 07630040720236
• 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): 06/09/2026

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: 01.18.434
• Device Lot Number: 2511598
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2025
• 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: Female