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

Catalog Number	01.18.401
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 march 2021: lot 2004808: (b)(4) items manufactured and released on 24-sep-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 other similar reported event.Additional implant involved: liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot.2009610.Batch review performed on 25 march 2021: lot 2009610: (b)(4) items manufactured and released on 16-oct-2020.Expiration date: 2025-10-12.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: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2006697.Batch review performed on 25 march 2021: lot 2006697: (b)(4) items manufactured and released on 28-sep-2020.Expiration date: 2025-09-22.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: batch review for cup: mpact 01.32.152dh acetabular shell ø52 two-holes (k132879) lot.2001283.Batch review performed on 25 march 2021: lot 2001283: (b)(4) items manufactured and released on 01-july-2020.Expiration date: 2025-06-23.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.Additional implant involved: liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot.2003333.Batch review performed on 24 march 2021: lot 2003333: (b)(4) items manufactured and released on 20-may-2020.Expiration date: 2025-05-18.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: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2006694.Batch review performed on 24 march 2021: lot 2006694: (b)(4) items manufactured and released on 02-oct-2020.Expiration date: 2025-09-24.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
The patient came in 1 month after the primary reporting pain due to falling.The surgeon observed redness and swelling at the incision site and decided to perform a washout and revise the head and liner.1 day after the revision the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11676929
• Report Number: 3005180920-2021-00305
• Device Sequence Number: 3610282
• Product Code: LZO
• UDI-Device Identifier: 07630040720007
• UDI-Public: 07630040720007
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2021

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: 09/21/2025
• Device Catalogue Number: 01.18.401
• Device Lot Number: 2004808
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/16/2021
• 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: 51 YR