MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P STD STEM SIZE 4; HIP CEMENTLESS STEM

Catalog Number	01.18.404
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 september 2020: lot 1901564: (b)(4) items manufactured and released on 21-may-2019.Expiration date: 2024-05-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other devices involved in the event ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 lot.1907335 (k112115).Batch review performed on 03 september 2020: lot 1907335: (b)(4) items manufactured and released on 21-jan-2020.Expiration date: 2025-01-08.No anomalies found related to the problem.To date,(b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.2 months after primary surgery the surgeon performed a washout and did not revise any components.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P STD STEM SIZE 4
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10567152
• Report Number: 3005180920-2020-00625
• Device Sequence Number: 2704628
• Product Code: LZO
• UDI-Device Identifier: 07630040720038
• UDI-Public: 07630040720038
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

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: 05/11/2024
• Device Catalogue Number: 01.18.404
• Device Lot Number: 1901564
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention