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

Device Problem Component Missing (2306)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.

Event Description

Full and standard inlays implant kit aequalis reversed was missing.Only the glenoid and long stem kit was delivered by our customer.In such cases it is to complicate for the or to control kits if no detailed list of parts is present in the confirmation of their order.As the glenoid and long set were already implanted when or nurse recognized the missing of inlays all of it had to be retrieved.A competitive product shoulder was then implanted.Impact for patient: longer surgery time (additional anesthesia time, surgical procedure had to be remade in one stage), greater loss of bone.

• Brand Name: AEQUALIS REVERSED INSERT
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer Contact: maud andriollo-sanchez ; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 9012276
• MDR Text Key: 159685009
• Report Number: 3000931034-2019-00138
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K030941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/02/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2019
• Initial Date FDA Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR