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

Model Number	SIZE 2C ANGLE 137.5° LENGTH 70MM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.
Event or Problem Description
Following the surgery where these ascend flex implants (another hospital in (b)(6)) were implanted, it was identified from a follow-up scan that the pyrocarbon humeral head had been damaged/cracked/shattered.This patient was referred to mr (b)(6) at (b)(6).It is believed that there were metal anchors from a historic soft tissue procedure in the glenoid and these could potentially have been a contributing factor to the implant damage.Mr (b)(6) had to remove every piece of the implant (apparently the initial surgeon performed an arthroscopic procedure after identifying the issue on the scans to try remove the metal anchors).The carbon had destroyed much of the patient's bony anatomy and a lot of the soft tissues had to be debrided to remove the carbon and clean the joint.A cement spacer was implanted and it is expected a custom implant will be required to revise this at some point.

• Brand Name: AEQUALIS ASCEND FLEX 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: 9012272
• Report Number: 3000931034-2019-00128
• Device Sequence Number: 19452156
• Product Code: KWS
• UDI-Device Identifier: 03700386944529
• UDI-Public: 03700386944529
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• 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 Model Number: SIZE 2C ANGLE 137.5° LENGTH 70MM
• Device Catalogue Number: DWF602C
• Device Lot Number: AB0067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 09/12/2019
• 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