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

Model Number	HEIGHT +9MM
Medical Device Problem Codes	Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.(please refer to medwatch report sent by hospital n° (b)(4)).
Event or Problem Description
Severe periprosthetic infection identified at the time of arthrotomy which was an unexpected finding.The shoulder was then dislocated and the modular components from the humeral stem explanted.At the interfaces of the modular components, extensive purulent material was identified.Any infected or necrotic appearing tissue was removed.With the modular components of the humeral stem removed, the more posterior aspects of the shoulder joint were debrided.Once all modular components were removed and sharp excisional debridement completed, a series of irrigation maneuvers was performed.3 l of sterile saline was irrigated through the joint using pulsatile lavage.This was followed by a 2-minute dilute hydrogen peroxide solution lavage and further pulsatile irrigation of 3 l sterile saline.This was then followed by a 3-minute dilute betadine lavage and an additional 3 l of sterile saline through pulsatile irrigation.At the conclusion of these irrigation maneuvers, a surgically clean shoulder joint was achieved.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device (please refer to medwatch report sent by hospital n° (b)(4)).

• Brand Name: AEQUALIS REVERSED FRACTURE SPACER
• 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: 8296301
• Report Number: 3000931034-2019-00019
• Device Sequence Number: 1991269
• Product Code: KWS
• UDI-Device Identifier: 03700386931888
• UDI-Public: 03700386931888
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K082120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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: 09/11/2022
• Device Model Number: HEIGHT +9MM
• Device Catalogue Number: DWD920
• Device Lot Number: 8569AS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 11/21/2019
• 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
• Patient Age: 76 YR
• Patient Weight: 98