MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE 38MM GLENOSPHERE

Model Number UNKNOWN

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Injury (2348)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to dislocation.The surgeon decided to do a revision because the patient fell and knocked their shoulder out of place.The surgeon opened the joint in regular fashion.He unlocked the +0 liner from the humeral adapter tray and retracted the stem and humerus out of the way.He then took out the 38 standard glenosphere.He then replaced it with a 38+4 lateralized glenosphere.After he put on the glenosphere, he went back to the stem and trialed a 38+2.5 liner.He liked how stable the shoulder was with that implant and told me to open it.He then implanted a 38 +2.5 liner.He then reduced the shoulder.He then closed the joint in standard fashion.

Manufacturer Narrative

The engineering evaluation reported this experience was likely the result of a patient fall, which likely led to dislocation.

Manufacturer Narrative

H11: (g4) the awareness date in the second follow up should have been (b)(6)2019.

Manufacturer Narrative

The following sections have corrected information: (g4) updated date received by manufacturer from 11-mar-2019 to 05-mar-2019.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE 38MM GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8490791
• MDR Text Key: 141165124
• Report Number: 1038671-2019-00220
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: 320-01-38
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention