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

Catalog Number	01.18.136
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 january 2018: (b)(4).
Event or Problem Description
Revision surgery was necessary due to bone fracture.

• Brand Name: AMISTEM H HA COATED STD STEM SIZE6
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7185746
• Report Number: 3005180920-2017-00838
• Device Sequence Number: 13801455
• 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: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2018

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: 03/31/2020
• Device Catalogue Number: 01.18.136
• Device Lot Number: 150018
• 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: 12/14/2017
• Initial Report FDA Received Date: 01/12/2018
• 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