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

Model Number	THREADED POST DIAM 29MM LG 35MM
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	09/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial 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.
Event or Problem Description
"this is one of dr (b)(6) previous patients, now taken care of by dr (b)(6).Originally dr (b)(6) did a biorsa (bone graft) with a threaded post baseplate.On xray there was a screw-like lucency around the central screw as if it had windshield-wipered its way loose.Patient came in with a dislocated adjustable reverse, with some obviously broken screws on xray, and radiolucency around the screw itself.".
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED II 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: 9257600
• Report Number: 3000931034-2019-00146
• Device Sequence Number: 14385499
• Product Code: KWS
• UDI-Device Identifier: 03700386952746
• UDI-Public: 03700386952746
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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 Model Number: THREADED POST DIAM 29MM LG 35MM
• Device Catalogue Number: DWE835
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 04/03/2020
• 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: 68 YR