MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; STEM: AMISTEM-P COLLARED 01.18.433 AMISTEM-P COLLARED STD. SIZE 3

Model Number	01.18.433
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2025.Lot 2114340: (b)(4) items manufactured and released on 09-feb-2022.Expiration date: 2027-01-31.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.Other devices involved: ball heads: mectacer 01.29.210 mectacer head biolox delta dia.36 12/14-l (k112115) lot 2011681: (b)(4) items manufactured and released on 11-mar-2021.Expiration date: 2026-02-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Cup: mpact 01.32.154mh acetabular shell ø54 multi-hole (k132879) lot 2106974: (b)(4) items manufactured and released on 26-oct-2021.Expiration date: 2026-10-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot 2111809: (b)(4) items manufactured and released on 27-sep-2021.Expiration date: 2026-09-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Screws: mpact 01.32.6515 cancellous bone screw, flat head ø 6,5 l 15 (k103721) lot 1908114: (b)(4) items manufactured and released on 18-oct-2019.Expiration date: 2024-10-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Screws: mpact 01.32.6520 cancellous bone screw, flat head ø 6,5 l 20 (k103721) lot 2115334: (b)(4) items manufactured and released on 16-nov-2021.Expiration date: 2026-nov-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.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.
Event or Problem Description
Revision surgery due to infection at about 2 years and 10 months post primary.The cup and stem were loose due to the infection.All devices revised successfully.

• Brand Name: AMISTEM-P COLLARED
• Common Device Name: STEM: AMISTEM-P COLLARED 01.18.433 AMISTEM-P COLLARED STD. SIZE 3
• 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: 21685775
• Report Number: 3005180920-2025-00223
• Device Sequence Number: 8730790
• Product Code: LZO
• UDI-Device Identifier: 07630040720229
• UDI-Public: 07630040720229
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/25/2025

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: 01.18.433
• Device Lot Number: 2114340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2022
• 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: 63 YR
• Patient Sex: Female