MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; LINER

Model Number SPECIFIC DEVICE NOT REPORTED

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation concomitant device(s): reverse humeral stem, humeral tray, glenosphere.

Event Description

As reported, a (b)(6) male patient who weighs (b)(6).Experienced a possible disassociation of poly liner of the right shoulder.Initial implant date is (b)(6) 2016.On (b)(6) 2019.A revision occurred due to disassociation of liner.Information received from clinical study database.

Event Description

As reported, approximately 3years 9 mos.Post op initial implant, a 66 y/o male patient who weighs 230 lb.Experienced a possible disassociation of poly liner of the right shoulder.The patient has a history of hypertension and osteoarthritis.A revision occurred due to disassociation of liner.Information received from clinical study database.Devices not returning due to facility policy.

Manufacturer Narrative

(h3) the revision reported was likely the result of incomplete seating of the liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or extreme wear of the liner, which led to the liner disassembling from the humeral tray.However, this cannot be confirmed because the part was not returned for evaluation.The following sections have corrected information: (b5) describe event or problem: as reported, approximately 3years 9 mos.Post op initial implant, a 66 y/o male patient who weighs 230 lb.Experienced a possible disassociation of poly liner of the right shoulder.The patient has a history of hypertension and osteoarthritis.A revision occurred due to disassociation of liner.Information received from clinical study database.Devices not returning due to facility policy.(g3) report source: should of been checked "health professional" on the initial submission.

• Brand Name: EQUINOXE
• Type of Device: LINER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9483412
• MDR Text Key: 176376414
• Report Number: 1038671-2019-00609
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 104