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

Model Number	CEMENTED DIAM.9MM LENGTH 100MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/14/2018
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
"subject had tenderness over humeral shaft.Xrays revealed loosening signs and lucency of the humeral component along the cement mantle.Patient id: (b)(6).".
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED
• 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: 7876494
• Report Number: 3000931034-2018-00128
• Device Sequence Number: 18866087
• Product Code: KWS
• UDI-Device Identifier: 03700386916212
• UDI-Public: 03700386916212
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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: No Information
• Device Expiration Date: 07/31/2015
• Device Model Number: CEMENTED DIAM.9MM LENGTH 100MM
• Device Catalogue Number: DWB945
• Device Lot Number: 2631AJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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: 79 YR
• Patient Weight: 64