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

Model Number	DIAM. 36MM LAT.+15MM
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	06/11/2020
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
Revision surgery due to local reaction and migration of the prosthesis (broad humeral lysis and migration).The bone scintigraphy showed signs of mobilization of prosthesis.During the surgical procedure for explant, presence of local metallosis (samples sent for anatomical examination and microbiological).All the components were removed.
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 RETENTIVE 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: 10331714
• Report Number: 3000931034-2020-00095
• Device Sequence Number: 826029
• Product Code: KWS
• UDI-Device Identifier: 03700386932717
• UDI-Public: 03700386932717
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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 Model Number: DIAM. 36MM LAT.+15MM
• Device Catalogue Number: DWD986
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 09/24/2020
• 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: 68 YR