MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM P STD STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.18.402
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed on december 14, 2018.Partial revision of cementless primary tha one month after primary.The reason for revision of head and liner was to optimize hip geometry.The stem was well integrated even after such a short time and could not be repositioned.No faulty device originated this problem.Batch review performed on 19 december 2018.Lot 179932: 70 items manufactured and released on 03 may 2018.Expiration date: 2023-04-23 no anomalies found related to the problem.To date, 47 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery 1 month and half after the primary surgery because the stem was too deep (1 cm), surgeon wanted to remove the stem and put a cemented amistem.The stem was impossible to be removed, so he decided to keep the stem and replace the others implants.

• Brand Name: AMISTEM P STD STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8178701
• Report Number: 3005180920-2018-01016
• Device Sequence Number: 1098741
• Product Code: LZO
• UDI-Device Identifier: 07630040720014
• UDI-Public: 07630040720014
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2018

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 Catalogue Number: 01.18.402
• Device Lot Number: 179932
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/19/2018
• 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