MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II BASE PLATE; SHOULDER JOINT METAL PROSTHESIS

Model Number	DWE825
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	06/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.
Event or Problem Description
"it was reported that a patient underwent a revision surgery for instability-dislocation.Total shoulder arthroplasty on (b)(6) 2002.Revision surgeries on (b)(6) 2015, (b)(6) 2016 and (b)(6) 2017 (aequalis press fit stem dwb273 + aequalis titanium humeral head dwa239).Patient id : (b)(6).".

• Brand Name: AEQUALIS REVERSED II BASE PLATE
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 7357551
• Report Number: 3000931034-2018-00040
• Device Sequence Number: 2023401
• Product Code: KWS
• UDI-Device Identifier: 03700386952722
• UDI-Public: 03700386952722
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K132285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2018

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: Physician
• Device Model Number: DWE825
• Device Catalogue Number: DIAM. 29MM THREADED POST L25MM
• 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: 02/23/2018
• Initial Report FDA Received Date: 03/21/2018
• 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: Other
• Patient Age: 70 YR
• Patient Weight: 75