MAUDE Adverse Event Report: TORNIER S.A.S. AEQ ASCEND FLEX STD HUMERAL STEM 5A ANGLE 127 DEGREES5 L.82 PTC; SHOULDER JOINT METAL PROSTHESIS

Model Number	DWF605A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Muscle Weakness/Atrophy (1967); Paralysis (1997); Loss of Range of Motion (2032)
Date of Event	04/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned as it remains implanted.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that on (b)(6) 2017 primary surgery took place of aequalis ascend flex + aequalis reversed ii glenoid.On (b)(6) 2018 (onset date unk (b)(6) 2017) adverse event was reported, pseudoparalytic right arm due to cervical spine degeneration and subsequent radiculopathy.Subject has been having increasing neck issues and has been advised to undergo surgical intervention.Subject is seeking a second opinion and emg to understand the problems.Subsequently on (b)(6) 2021, patient sustain a c1 fracture in (b)(6) 2020 leaving her unable to move her right arm at all now.Patient being followed by a neurosurgeon for cervical spine issues.

• Brand Name: AEQ ASCEND FLEX STD HUMERAL STEM 5A ANGLE 127 DEGREES5 L.82 PTC
• 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: 12593798
• Report Number: 3000931034-2021-00324
• Device Sequence Number: 1296649
• Product Code: KWS
• UDI-Device Identifier: 03700386944598
• UDI-Public: 03700386944598
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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: DWF605A
• Device Catalogue Number: DWF605A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 10/07/2021
• 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
• Patient Age: 68 YR
• Patient Weight: 63