MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P COLLARED STD STEM SIZE 5; HIP STEM CEMENTLESS

Model Number	01.18.435
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 january 2022 lot 2011566: 65 items manufactured and released on 03-feb-2021.Expiration date: 2026-jan-24.No anomalies found related to the problem.To date, 47 items of the same lot have been sold without any similar reported event.Additional components involved: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2103156: 388 items manufactured and released on 01-july-2021.Expiration date: 2026-jun-15.No anomalies found related to the problem.To date, 322 items of the same lot have been sold without any similar reported event.Liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721) lot.2000183: 200 items manufactured and released on 10-march-2020.Expiration date: 2025-feb-19.No anomalies found related to the problem.To date, 182 items of the same lot have been sold with 2 similar reported event.Cup: mpact 01.32.158dh acetabular shell ø58 two-holes (k132879) lot.2104466: 92 items manufactured and released on 28-june-2021.Expiration date: 2026-jun-13.No anomalies found related to the problem.To date, 52 items of the same lot have been sold without any similar reported event.
Event or Problem Description
At 1 month after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all implants, performed a washout and then re-implanted the patient with permanent hardware.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P AMISTEM-P COLLARED STD STEM SIZE 5
• 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: 13469421
• Report Number: 3005180920-2022-00080
• Device Sequence Number: 3886455
• Product Code: LZO
• UDI-Device Identifier: 07630040720243
• UDI-Public: 07630040720243
• 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: 2022
• 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): 02/07/2022

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: 01/24/2026
• Device Model Number: 01.18.435
• Device Catalogue Number: 01.18.435
• Device Lot Number: 2011566
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2021
• 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: Male