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

Model Number	314-02-02
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/05/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2021-00644
• Device Sequence Number: 20040644
• Product Code: KWT
• UDI-Device Identifier: 10885862084477
• UDI-Public: 10885862084477
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White