MAUDE Adverse Event Report: TORNIER S.A.S AEQUALIS ASCEND FLEX; PROSTHESIS SHOULDER METAL

Model Number	REVERSED TRAY TH +0 OFFSET 3,5MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2020 stryker trauma and extremities acquired tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr process.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.Pain can be related to several known reasons: infection.Implant material sensitivity.Consequence of the surgical procedure (improper positioning or inadequate choice of the implants components).Potential complication (such as loosening, disassembly problem, which could not be confirmed as the patient did not go for medical examination).Post-operative traumatic event.Reeducation procedure not respected or inadequate patient use in post-op (surgeon advices not respected).- moreover, as the patient pain is localized throughout the upper member, the pain could be also due to neurological complications ("the pain is all the way into neck and my hand", "numb", "tingling").Based on the low available information, there is no evidence that this case is related to the device, root cause cannot be clearly determined.
Event or Problem Description
Pain is traveling and is so severe at times.All into neck and down arm.Surgery in 2016 got better but 6 months ago, my arm is much more painful.I have 105 + 2 lot of mobility in it.Can't afford to go to dr and checked.I am on.Was doing really good on healing.6 months ago started getting weaker.The pain is all the way into neck and my hand is numb and tingling.Elbow pain.Can't afford to go to doctor.

• Brand Name: AEQUALIS ASCEND FLEX
• Common Device Name: PROSTHESIS SHOULDER METAL
• Manufacturer (Section D): TORNIER S.A.S; 161 rue lavoisier; montbonnot saint martin, ; FR
• Manufacturer Contact: laurent ray ; 161 rue lavoisier; montbonnot saint martin ; FR
• MDR Report Key: 13607073
• Report Number: 3000931034-2022-00106
• Device Sequence Number: 11245303
• Product Code: KWS
• UDI-Device Identifier: 03700386941078
• UDI-Public: 03700386941078
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2020

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: REVERSED TRAY TH +0 OFFSET 3,5MM
• Device Catalogue Number: DWF520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown