MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 6; CEMENTLESS HIP STEM

Catalog Number	01.18.146
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 november 2018: lot 150151: (b)(4) items manufactured and released on 20 may 2015.Expiration date: 2020-04-30.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed on november 16, 2018 by clinical affairs director: approx.3 years after primary cementless tha the stem was found to be loose and replaced.From the radiographs supplied we were unable to identify any possible cause related to malposition or suboptimal dimensioning of the stem.Such an early loosening is unlikely to be caused by simply mechanical reasons, however there is no report of an infection or other adverse reaction.Therefore, the causes for this revision cannot be identified with the information at hand.
Event or Problem Description
Revision surgery performed after 2 years and 9 months from primary due to acute hip pain caused by loosening of the distal part of the stem.The amistem-h was replaced with quadra-r.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 6
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8077514
• Report Number: 3005180920-2018-00911
• Device Sequence Number: 195024
• Product Code: LZO
• UDI-Device Identifier: 07630030804229
• UDI-Public: 07630030804229
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 11/16/2018

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 Expiration Date: 04/30/2020
• Device Catalogue Number: 01.18.146
• Device Lot Number: 150151
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/16/2018
• 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