MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 0; CEMENTLESS STEM

Catalog Number	01.18.400
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 april 2021: lot 1811092: (b)(4) items manufactured and released on 2-apr-2019.Expiration date: 2024-03-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional item involved in the event: ball heads: cocr 01.25.021 cocr ball head 12/14 ø 32 size s -3.5 (k072857) lot.1905318 batch review performed on 30 april 2021: lot 1905318: (b)(4) items manufactured and released on 20-nov-2019.Expiration date: 2024-11-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
11 months after the primary surgery the patient had a 1.5cm too long leg, therefore the surgeon decided to remove the stem and to put a new one, trying to shorten the leg.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 0
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11848921
• Report Number: 3005180920-2021-00399
• Device Sequence Number: 3237371
• Product Code: LZO
• UDI-Device Identifier: 07630040719995
• UDI-Public: 07630040719995
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2021

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: 03/25/2024
• Device Catalogue Number: 01.18.400
• Device Lot Number: 1811092
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/19/2021
• 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