MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS RESURFACING HEAD

Model Number	43X16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device was manufactured in accordance with our specifications.Root cause of reported event could not be confirmed.This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
It was reported that: "revision surgery due to loosening/lysis".A tornier aequalis resurfacing head component was removed and replaced by a tornier reversed prosthesis.Revision surgery date (b)(6) 2016.Primary surgery(b)(6) 2010.Patient id: (b)(6).

• Brand Name: AEQUALIS RESURFACING HEAD
• Common Device Name: AEQUALIS RESURFACING HEAD
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 5722682
• Report Number: 3000931034-2016-00067
• Device Sequence Number: 10918237
• Product Code: HSD
• UDI-Device Identifier: 03700386926945
• UDI-Public: 03700386926945
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K131231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2016

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: No Information
• Device Expiration Date: 03/31/2014
• Device Model Number: 43X16
• Device Catalogue Number: DWD804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2016
• Initial Report FDA Received Date: 06/14/2016
• 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: Other
• Patient Age: 62 YR
• Patient Weight: 85