MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H HA COATED LAT STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.18.142
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed on 22 december 2017 by medical affairs department: approximately 6 years after primary cementless tha the femoral stem is found loose and replaced.The one image supplied shows significant signs of stress shielding and distal load transfer.There are no previous images that may help reconstructing the development of this situation.The sizing of the stem to the femoral bone cannot be evaluated having only the pre-revision xray in one projection.The root cause of this adverse event cannot be determined.Preliminary investigation performed by r&d project manager on 16 january 2018: the revised stem appeared without any particular sign; ha coating seems to be totally absorbed and blood coats some areas of the surface.From the received image it is not possible to determine the root cause of the event.Batch review performed on 18 january 2018: lot 112644: (b)(4) items manufactured and released on 26 sept 2011.Expiration date: 2016-08-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery was necessary 5 years anf 10 months after primary due to stem loosening.

• Brand Name: AMISTEM-H HA COATED LAT STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7206137
• Report Number: 3005180920-2017-00850
• Device Sequence Number: 1173303
• Product Code: LZO
• UDI-Device Identifier: 07630030804182
• UDI-Public: 07630030804182
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2018

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 Expiration Date: 08/31/2016
• Device Catalogue Number: 01.18.142
• Device Lot Number: 112644
• 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: 12/20/2017
• Initial Report FDA Received Date: 01/19/2018
• 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
• Patient Age: 57 YR
• Patient Weight: 80