MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 3; CEMENTLESS STEM

Catalog Number	01.18.403
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 april 2021: lot 2007168: (b)(4) items manufactured and released on 08-oct-2020.Expiration date: 2025-09-28.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.Additional items involved in the event: liner: mpact dm 01.26.2848mhc double mobility hc liner ø 48/28 (k092265) lot.2008277 batch review performed on 22 april 2021: lot 2008277: (b)(4) items manufactured and released on 22-oct-2020.Expiration date: 2025-10-11.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.Ball heads: cocr 01.25.011 cocr ball head 12/14 ø 28 size s -3.5 (k072857) lot.2007978 batch review performed on 22 april 2021: lot 2007978: (b)(4) items manufactured and released on 30-oct-2020.Expiration date: 2025-10-13.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.Cup: mpact 01.32.148mb double mobility acetabular shell ø48 (k143453) lot.2004885 batch review performed on 22 april 2021: lot 2004885: (b)(4) items manufactured and released on 30-sept-2020.Expiration date: 2025-09-21.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
On (b)(6) 2021, about 2 months and a half after primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components and implanted competitor implants.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 3
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11806093
• Report Number: 3005180920-2021-00381
• Device Sequence Number: 14364194
• Product Code: LZO
• UDI-Device Identifier: 07630040720021
• UDI-Public: 07630040720021
• Combination Product (Y/N): N
• 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: 2021
• Device Explanted Year: 2021
• 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): 05/10/2021

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: 09/28/2025
• Device Catalogue Number: 01.18.403
• Device Lot Number: 2007168
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/11/2021
• 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: 74 YR