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

Model Number	SIZE 2B 132.5° 93MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial 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
After the initial ascend flex reversed surgery on (b)(6) 2017,this patient had a revision surgery twice for dislocation reasons.The first revision surgery was performed on (b)(6) 2017, and the insert was replaced.The second revision surgery was performed on (b)(6) 2017, and all implants were replaced (reports mdr # 3000931034-2017-00148 and # 3000931034-2017-00149).At this time, infection of the affected area was also found.On (b)(6) 2019, this patient fell down and around the distal part of the implanted stem was fractured.A third revision surgery was performed on (b)(6) 2019 for infection: removal of the stem, cleaning, and insertion of a cement mold.
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.

• 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: 9318750
• Report Number: 3000931034-2019-00161
• Device Sequence Number: 468547
• Product Code: KWS
• UDI-Device Identifier: 03700386944789
• UDI-Public: 03700386944789
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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: 01/25/2025
• Device Model Number: SIZE 2B 132.5° 93MM
• Device Catalogue Number: DWF612B
• Device Lot Number: 0485AS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 04/08/2020
• 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: 79 YR