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

Catalog Number	01.18.415
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 april 2021.Lot 182545: (b)(4) items manufactured and released on 19-sep-2018.Expiration date: 2023-09-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved: cup: mpact 01.32.156mb double mobility acetabular shell ø56 (k143453) lot.1900195.Batch review performed on 06 april 2021.Lot 1900195: (b)(4) items manufactured and released on 18-june-2019.Expiration date: 2024-06-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved: liner: mpact dm 01.26.2856mhc double mobility hc liner 28/dmh (k092265) lot.1901458.Batch review performed on 06 april 2021.Lot 1901458: (b)(4) items manufactured and released on 13-may-2019.Expiration date: 2024-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.Another similar event has been reported on this lot.Additional implant involved: ball heads: mectacer 01.29.203 biolox delta ceramic ball head 12/14 ø 28 size l +3.5 (k112115) lot.1900794.Batch review performed on 06 april 2021.Lot 1900794: (b)(4) items manufactured and released on 08-may-2019.Expiration date: 2024-04-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Signs of infection 1 year 6 months after the primary and the pathogen is unknown.The surgeon removed successfully all implants and implanted an antibiotic spacer.

• Brand Name: STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 5
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11744397
• Report Number: 3005180920-2021-00338
• Device Sequence Number: 4113170
• Product Code: LZO
• UDI-Device Identifier: 07630040720144
• UDI-Public: 07630040720144
• 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: 2019
• 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): 04/29/2021

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: 09/06/2023
• Device Catalogue Number: 01.18.415
• Device Lot Number: 182545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/29/2021
• 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