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

Model Number	CEMENTED STEM DIA. 6.5 LG 100 MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
Following the surgery where these reverse ii implants were implanted (another hospital in (b)(6)), the patient underwent a follow up scan and it was identified that the reversed ii stem and metaphysis components were detached/detaching (unscrewed).This patient was then referred to mr (b)(6) at (b)(6) to revise and fix this issue.Mr (b)(6) was able to remove these components.

• 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: 8969045
• Report Number: 3000931034-2019-00127
• Device Sequence Number: 19496686
• Product Code: KWS
• UDI-Device Identifier: 03700386916175
• UDI-Public: 03700386916175
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2019

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: Lay User/Patient
• Device Expiration Date: 03/09/2023
• Device Model Number: CEMENTED STEM DIA. 6.5 LG 100 MM
• Device Catalogue Number: DWB940
• Device Lot Number: AB7532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/06/2019
• 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