MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C FEMORAL STEMS; AMISTEM-C LAT. SIZE 3

Model Number	01.18.103
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 june 2026 stem: amistem c 01.18.103 amistem-c lat.Size 3 (k103189) lot.2104302: (b)(4) items manufactured and released on 29 july 2021.Expiration date: 14 july 2026.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.Ball heads: cocr 01.25.124 cocr ball head 12/14 d 22.2 mm size s (k080885) lot.2302187: (b)(4) items manufactured and released on 12 april 2023.Expiration date: 25 march 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.Ball heads: bipolar head 25060.2243 316lvm bipolar head d 22.2 x 43 (k091967) lot.2319184: (b)(4) items manufactured and released on 05 february 2024.Expiration date: 13 january 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: 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
The patient came in due to signs of infection and the pathogen is unknown.About 1 month after the primary surgery, the surgeon performed a washout, and revised all component successfully.

• Brand Name: AMISTEM C FEMORAL STEMS
• Common Device Name: AMISTEM-C LAT. SIZE 3
• 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: 25442543
• Report Number: 3005180920-2026-00561
• Device Sequence Number: 5727573
• Product Code: LZO
• UDI-Device Identifier: 07630030803819
• UDI-Public: 07630030803819
• Combination Product (Y/N): N
• PMA/510(K) Number: K103189
• 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 Expiration Date: 07/14/2026
• Device Model Number: 01.18.103
• Device Lot Number: 2104302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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