MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED FRACTURE INSERT; SHOULDER JOINT POLYMER PROSTHESIS

Model Number LATERALIZED INSERT D36MM LAT+6MM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Patient Problem/Medical Problem (2688)

Event Date 09/17/2018

Event Type  Injury  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.

Event Description

"it was reported that a patient underwent a revision surgery for instability/dislocation 5 days post-operative.Subject id: (b)(6).".

• Brand Name: AEQUALIS REVERSED FRACTURE INSERT
• Type of Device: SHOULDER JOINT POLYMER PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• Manufacturer Contact: maud andriollo ; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 8199145
• MDR Text Key: 131489921
• Report Number: 3000931034-2018-00189
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386931499
• UDI-Public: 03700386931499
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/16/2023
• Device Model Number: LATERALIZED INSERT D36MM LAT+6MM
• Device Catalogue Number: DWD860
• Device Lot Number: 9460AT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 79