MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS HUMERAL HEAD; SHOULDER JOINT METAL PROSTHESIS

Model Number	37X13.5
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
It was reported that the patient underwent revision surgery at 9 months post-operative due to rotator cuff tear and loosening of the stem.The implanted stem, humeral head and glenoid component were removed.Conversion into rsa.Surgeon's comment: he should have done rsa instead of tsa.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS HUMERAL HEAD
• 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: 6025995
• Report Number: 3000931034-2016-00149
• Device Sequence Number: 10834746
• Product Code: KWS
• UDI-Device Identifier: 03700386915499
• UDI-Public: 03700386915499
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K012212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2016

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: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: 37X13.5
• Device Catalogue Number: DWB237
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/16/2016
• Supplement Date Received by Manufacturer: 09/16/2016
• Initial Report FDA Received Date: 10/13/2016
• Supplement Report FDA Received Date: 01/03/2018
• 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: 75 YR
• Patient Weight: 60