MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED STD STEM SIZE6; CEMENTLESS HIP STEM

Catalog Number	01.18.136
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs on 16 february 2018: hip revision surgery occurred 5,5 years after primary cementless total hip arthroplasty.Radiographic image provided shows the presence of a mobilized stem.Aseptic loosening is a possible, literature described adverse event after cementless tha and causes are often unknown.In this case, reason of failure cannot be determined.Batch review performed on 26 february 2018 lot 120924: (b)(4) items manufactured and released on 22 june 2012.Expiration date: 2017-05-31 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
The patient came in complaining of instability 5 years and 5 months after primary.The cause is unknown.The stem came out very easily, took no time with the medacta stem extractor.

• Brand Name: AMISTEM H HA COATED STD STEM SIZE6
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7306125
• Report Number: 3005180920-2018-00102
• Device Sequence Number: 1261015
• Product Code: LZO
• UDI-Device Identifier: 07630030804120
• UDI-Public: 07630030804120
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2018

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: 05/31/2017
• Device Catalogue Number: 01.18.136
• Device Lot Number: 120924
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 03/01/2018
• 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
• Patient Age: 49 YR