MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; HIP STEM

Model Number	01.18.442
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At 1 month from the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon revised all medacta hardware and reimplanted permanent product.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 19 aug 2024.Lot 2007801: (b)(4) items manufactured and released on 10-dec-2020.Expiration date: 2025-11-26.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 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 2405095: (b)(4) items manufactured and released on 15-mar-2024.Expiration date: 2029-02-27.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 acetabular shell ø54 two-holes (k132879) lot 2343856: (b)(4) items manufactured and released on 08-may-2024.Expiration date: 2029-04-21.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 flat pe hc liner ø36/e (k103721) lot 2348564: (b)(4) items manufactured and released on 15-jan-2024.Expiration date: 2028-12-27.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.Screws: mpact cancellous bone screw ø 6,5 l 25 (k200391) lot 2319119: (b)(4) items manufactured and released on 13-sept-2023.Expiration date: 2028-08-26.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.

• Brand Name: AMISTEM-P COLLARED
• Common Device Name: HIP STEM
• 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: 20426054
• Report Number: 3005180920-2024-00806
• Device Sequence Number: 15419000
• Product Code: LZO
• UDI-Device Identifier: 07630040720311
• UDI-Public: 07630040720311
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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: 11/26/2025
• Device Model Number: 01.18.442
• Device Lot Number: 2007801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2020
• 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