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

Model Number	DIAM 29MM
Medical Device Problem Codes	Disassembly (1168); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Fall (1848); Unspecified Infection (1930)
Date of Event	01/09/2018
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
"2014 aequalis reversed operation.On (b)(6) 2018: the patient fell which may have caused loosening of glenoid sphere and baseplate.As a little swelling and pus were seen in the insertion site, the surgeon decided to remove the implants.(b)(6) 2018: as the infection was only the surface of the skin, only the glenoid sphere, insert and baseplate were removed and a head was implanted.Comment from surgeon: if infection was very serious, i was going to remove all the implants but it was not so serious, so i just left the stem and implanted a head.This patient seemed to have some kind of infection after the surgery 4 years ago but it did not become serious.So, this component loosening can be the cause of this incident.".
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED BASEPLATE
• 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: 7285264
• Report Number: 3000931034-2018-00019
• Device Sequence Number: 16512808
• Product Code: KWS
• UDI-Device Identifier: 03700386916618
• UDI-Public: 03700386916618
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

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: DIAM 29MM
• Device Catalogue Number: DWD002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 08/16/2018
• 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