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

Model Number	DIAMETER 9MM LENGTH 100MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/02/2018
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
Patient reached out to wright via (b)(6) personal message.Provided a pdf with description of incident and x-rays: "since (b)(6) 2017, i have a new aequalis reversed ii shoulder system, thanks to which, after several months of physiotherapy, i was able to raise my arm again after 17 years of not being able to do it.I felt very happy with my new prostheses because i could practice cycling again, but a month ago, on (b)(6) 2018, after climbing two floors with a fourteen pounds suitcase in each arm, (15 lbs.Each), the rx showed the broken and disassembled prosthesis.Could someone of wright medical group explain to me why this fault happened and what is the procedure to follow? my doctor is baffled since he had never seen a similar prosthesis disassembly and i am completely incapacitated.On (b)(6) 2018, the patient couldn't raise arm after carrying 2 suitcases up 2 floors.The revision surgical intervention was planned for (b)(6) 2018, but my surgeon preferred to consult my case with the best surgeons in the world in the (b)(6) international shoulder course on (b)(6) 2019.".
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED STEM
• 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: 8288408
• Report Number: 3000931034-2019-00018
• Device Sequence Number: 2141655
• Product Code: KWS
• UDI-Device Identifier: 03700386916212
• UDI-Public: 03700386916212
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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 Expiration Date: 06/23/2022
• Device Model Number: DIAMETER 9MM LENGTH 100MM
• Device Catalogue Number: DWB945
• Device Lot Number: AB1663
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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: 63 YR