MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS PERFORM REVERSED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWJ023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient experienced sudden onset of increasing pain in the left shoulder and loss of active motion.It was found on ct scans that the patient suffered an acromion fracture.The implants are still in good position.Patient was instructed to wear a sling for 1 month & take (b)(6).Patient returned to the clinic one month later and was improving.

• Brand Name: AEQUALIS PERFORM REVERSED
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• MDR Report Key: 12362695
• Report Number: 3000931034-2021-00315
• Device Sequence Number: 14437187
• Product Code: PHX
• UDI-Device Identifier: 00846832061945
• UDI-Public: 00846832061945
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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: Lay User/Patient
• Device Model Number: DWJ023
• Device Catalogue Number: DWJ023
• Device Lot Number: CZ152012013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/24/2021
• 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