MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P STD SIZE 7; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.407
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 june 2021: lot 2009285: (b)(4) items manufactured and released on 02-12-2020.Expiration date: 2025-11-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation: early infection in cementless tha, few weeks after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Additional implants involved: batch review performed on 24 june 2021: cup: versafitcup cc trio 01.26.45.0054 acetabular shell cc trio ø 54 (k103352) lot 2009363: (b)(4) items manufactured and released on 21-dec-2020.Expiration date: 2025-12-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 2009405: (b)(4) items manufactured and released on 19-jan-2021.Expiration date: 2026-01-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Liner(not registered in usa): mectacer 01.29.413 ceramic liner ø 36 / e lot 2009426: (b)(4) items manufactured and released on 21-jan-2021.Expiration date: 2026-01-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in due to signs of infection and the pathogen has been identified as staph aureus.1 month after the primary the surgeon revised all implants and the surgery was completed successfully.

• Brand Name: STEM: AMISTEM P STD SIZE 7
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12058169
• Report Number: 3005180920-2021-00511
• Device Sequence Number: 3975735
• Product Code: LZO
• UDI-Device Identifier: 07630040720069
• UDI-Public: 07630040720069
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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: 11/24/2025
• Device Catalogue Number: 01.18.407
• Device Lot Number: 2009285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/24/2021
• 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
• Patient Age: 52 YR
• Patient Weight: 89