MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM P LAT STEM SIZE 6; HIP CEMENTLESS STEM

Catalog Number	01.18.416
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month after primary, the patient came in reporting pain due to subsidence of the cup and stem loosening.The surgeon revised successfully the cup, liner, head and stem.
Additional Manufacturer Narrative
Batch review performed on 05-aug-2024 lot 2304086: (b)(4) items manufactured and released on 30-jun-2023.Expiration date: 2028-06-13.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 device involved batch review performed on 05-aug-2024 cup: mpact 01.32.148dh acetabular shell ø48 two-holes (k132879) lot 2316704: (b)(4) items manufactured and released on 22-nov-2023.Expiration date: 2028-11-01.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 LAT STEM SIZE 6
• Common Device Name: HIP CEMENTLESS 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: 20050064
• Report Number: 3005180920-2024-00665
• Device Sequence Number: 7933614
• Product Code: LZO
• UDI-Device Identifier: 07630040720151
• UDI-Public: 07630040720151
• 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): 08/23/2024

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 Catalogue Number: 01.18.416
• Device Lot Number: 2304086
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2023
• 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