MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 1; HIP STEM CEMENTLESS

Model Number	01.18.431
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 march 2022: lot 2009295: (b)(4) items manufactured and released on 25-nov-2020.Expiration date: 2025-11-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional components involved: liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot.2105807: (b)(4) items manufactured and released on 15-june-2021.Expiration date: 2026-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Cup: mpact 01.32.150dh acetabular shell ø50 two-holes (k132879) lot.2109422: (b)(4) items manufactured and released on 04-nov-2021.Expiration date: 2026-10-19.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 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot.2109336: (b)(4) items manufactured and released on 26-oct-2021.Expiration date: 2026-10-12.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 an infection and the pathogen is unknown.At 2 month from primary the surgeon removed all components and implanted a spacer.The pathogen is unknown.

• Brand Name: STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 1
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13860768
• Report Number: 3005180920-2022-00202
• Device Sequence Number: 4666592
• Product Code: LZO
• UDI-Device Identifier: 07630040720205
• UDI-Public: 07630040720205
• 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: 2022
• Device Explanted Year: 2022
• 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): 03/22/2022

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: 11/10/2025
• Device Model Number: 01.18.431
• Device Catalogue Number: 01.18.431
• Device Lot Number: 2009295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2020
• 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