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

Model Number	01.18.445
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20-january-2022.Lot 2003964: (b)(4) items manufactured and released on 26-aug-2020.Expiration date: 2025-aug-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional items involved in the event, batch review performed on 20-january-2022: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 2012923.Lot 2012923: (b)(4) items manufactured and released on 15-apr-2021.Expiration date: 2026-mar-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event.Liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot.2010842.Lot 2010842: (b)(4) items manufactured and released on 04-nov-2020.Expiration date: 2025-oct-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event.Screws: mpact 01.32.6525 cancellous bone screw, flat head ø 6,5 l 25 (k103721) lot.2110796 lot 2110796: (b)(4) items manufactured and released on 24-sep-2021.Expiration date: 2026-sep-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Screws: mpact 01.32.6525 cancellous bone screw, flat head ø 6,5 l 25 (k103721) lot.2013778 lot 2013778: (b)(4) items manufactured and released on 12-feb-2021.Expiration date: 2026-jan-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Cup: mpact 01.32.152dh acetabular shell ø52 two-holes (k132879) lot.2105760 lot 2105760: (b)(4) items manufactured and released on 25-aug-2021.Expiration date: 2026-aug-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.About 1 month after the primary surgery, the surgeon removed all components, performed a washout, and reimplanted permanent hardware.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM-P COLLARED LAT STEM SIZE 5
• Common Device Name: COLLARED AMISTEM-P
• 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: 13535309
• Report Number: 3005180920-2022-00090
• Device Sequence Number: 4072959
• Product Code: LZO
• UDI-Device Identifier: 07630040720342
• UDI-Public: 07630040720342
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2022

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: 08/06/2025
• Device Model Number: 01.18.445
• Device Catalogue Number: 01.18.445
• Device Lot Number: 2003964
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2022
• Initial Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2020
• 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: Male