MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P; AMISTEM-P LAT. SIZE 3

Model Number	01.18.413
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
After 4 months from the primary, the patient came in due to an infection with an unknown cause.The implants were removed and replaced with a competitor antibiotic cement spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 06 august 2025 stem: amistem p 01.18.413 amistem-p lat.#3 (k173794) lot.2403882: (b)(4) items manufactured and released on 17-june-2024.Expiration date: 03-june-2029.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 devices also revised: ball heads: mectacer 01.29.210 36 mm biolox delta head l (k112115) lot.2430511: (b)(4) items manufactured and released on 19-nov-2024.Expiration date: 03-nov-2029.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.Mpact 01.32.158 dht acetabular shell ø58 two-holes t (k230011) lot.2431475: (b)(4) items manufactured and released on 14-feb-2025.Expiration date: 28-jan-2030.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.Screw: mpact 3d metal iliac screw 01.43.0025 cancellous bone screw ø 6,5 l25(k200391) lot.2431117 : (b)(4) items manufactured and released on 07-jan-2025.Expiration date: 10-dec-2029.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.Screw: mpact 3d metal iliac screw 01.43.0035 cancellous bone screw ø 6,5 l35 (k200391) lot.2413348: (b)(4) items manufactured and released on 16 -july-2024.Expiration date: 30-june-2029.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.Liner: mectacer 01.32.3652 hct flat pe hc liner ø36/g (k103721) lot.2430447: (b)(4) items manufactured and released on 14 -jan-2025.Expiration date: 16 -dec -2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with a 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
• Common Device Name: AMISTEM-P LAT. 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: 22894259
• Report Number: 3005180920-2025-00807
• Device Sequence Number: 21078816
• Product Code: LPH
• UDI-Device Identifier: 07630040720120
• UDI-Public: 07630040720120
• 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: 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): 08/26/2025

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: 01.18.413
• Device Lot Number: 2403882
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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: Male