MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED HUMERAL INSERT; SHOULDER JOINT POLYMER PROSTHESIS

Model Number	LATERALIZED 36 X 6 MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/30/2020
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
On (b)(6) 2017, this patient had an initial surgery of aequalis reverse at (b)(6) orthopedics hospital.On (b)(6) 2020, an infection was found at the affected part at the same hospital.On (b)(6) 2020, a revision surgery was performed at (b)(6) medical center.After removing all the implants,the mold cement which includes antibiotics was implanted to the humeral and the surgery was completed.After several months of follow-up, another revision surgery might be performed for new implants depending on the recovery situation.
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 REVERSED HUMERAL INSERT
• Common Device Name: SHOULDER JOINT POLYMER PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 10475817
• Report Number: 3000931034-2020-00108
• Device Sequence Number: 11503649
• Product Code: KWS
• UDI-Device Identifier: 03700386916540
• UDI-Public: 03700386916540
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2020

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 Expiration Date: 11/02/2021
• Device Model Number: LATERALIZED 36 X 6 MM
• Device Catalogue Number: DWB993
• Device Lot Number: AA7316
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 10/13/2020
• 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