MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOID, PEGGED ALPHA, SMALL

Model Number 314-02-02

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 11/05/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: device evaluated by manufacturer: pending evaluation.Concomitant medical products: stemless humeral head 41mm x 13mm x alpha, cn: 310-62-41, sn: unknown.Stemless humeral comp laser cage, size 1, cn: 300-60-01, sn: unknown.

Event Description

This (b)(6) female patient presented with dissociation of polyethylene liner without traumatic incident.Shoulder is also dislocated anteriorly.And was converted to rtsa of the right shoulder.Outcome reported as resolved.

Manufacturer Narrative

(h3) the revision reported may have been the result of joint instability, which allowed for the glenoid to loosen and disassociate from the glenoid bone and the shoulder to dislocate anteriorly.However, this cannot be confirmed because the components were not returned to exactech for evaluation.

• Brand Name: EQUINOXE
• Type of Device: GLENOID, PEGGED ALPHA, SMALL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12900718
• MDR Text Key: 281529722
• Report Number: 1038671-2021-00644
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862084477
• UDI-Public: 10885862084477
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 314-02-02
• Device Catalogue Number: 314-02-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White