MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; AMISTEM-P COLLARED STD STEM SIZE 1

Model Number	01.18.431
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon needed a drainage at the incision site 2 weeks post-op for infection.The surgeon revised the stem, head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch reviews performed on 15 october 2025: stem: amistem-p collared 01.18.431 amistem-p collared std.Size 1 (k173794) lot: 2434824: (b)(4) items manufactured and released on 16-apr-2025.Expiration date: 2030-04-03.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.Additional implants involved, batch reviews performed on 15 october 2025: liner: versafitcup dm 01.26.2846mhc double mobility hc liner ø28/dmc (k241767) lot: 2338169: (b)(4) items manufactured and released on 12-dec-2023.Expiration date: 2028-11-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Ball heads: mectacer 01.29.202 mectacer head biolox delta dia.28 12/14-m (k112115) lot: 2513905: (b)(4) items manufactured and released on 11-jun-2025.Expiration date: 2030-05-18.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.Conclusions: 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 STEM SIZE 1
• 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: 23411609
• Report Number: 3005180920-2025-01053
• Device Sequence Number: 18749865
• Product Code: LPH
• UDI-Device Identifier: 07630040720205
• UDI-Public: 07630040720205
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: LPH
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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: 01.18.431
• Device Lot Number: 2434824
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• 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: Unknown