MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; AMISTEM-P COLLARED STD. SIZE 00

Model Number	01.18.429
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient has a primary hip surgery on (b)(6) 2025.On (b)(6) 2025, the patient came in reporting pain due to a dislocation of the head from the liner.The surgeon revised the liner, head and cup (mdr 2025-01040).Presently, the patient came in due to an infection and the pathogen is unknown.The surgeon performed a washout and revised the medacta stem and head with another medacta stem and head and revised the medacta cup and liner with a competitor`s products.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 16-dec-2025 stem: amistem-p collared 01.18.429 amistem-p collared std stem size 00 (k173794) lot.2425078: (b)(4) items manufactured and released on 07-jan-2025 expiration date: 2029-12-15.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.Ball heads: mectacer 01.29.203 28mm biolox delta head l (k112115) lot.2464191: (b)(4) items manufactured and released on 05-may-2025 expiration date: 2030-04-15.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: mpact dm 01.26.2850mhc double mobility hc liner d 28/dme (k092265) lot.2508205: (b)(4) items manufactured and released on 23-jun-2025 expiration date: 2030-06-03.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.Cup: mpact 01.32.150mb mpact dm acetabular shell d 50 (k143453) lot.2501789: (b)(4) items manufactured and released on 23-07-2025 expiration date: 2030-07-07.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.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. SIZE 00
• 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: 23858475
• Report Number: 3005180920-2025-01285
• Device Sequence Number: 21426275
• Product Code: LZO
• UDI-Device Identifier: 07630040720182
• UDI-Public: 07630040720182
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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: 01.18.429
• Device Lot Number: 2425078
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2025
• 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 Age: 51 YR
• Patient Sex: Female
• Patient Race: White