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

Device Problems Loose or Intermittent Connection (1371); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): replicator plate (cn: not reported), humeral head (cn: not reported).

Event Description

It was reported that the primary surgery was done on (b)(6) 2016.The patient has had a revision due to aseptic glenoid loosening.Glenoid loosening in relation with instability since 2017 with increase of shoulder impairment and pain.

Manufacturer Narrative

Section h10: (b2) outcomes attributed to adverse event: added check for required intervention to prevent permanent impairment/damage (devices) (h3) the revision reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed as the explanted devices were not available for evaluation.(h6) evaluation codes: 1924, 4002.*no information provided in the following section(s): b6, d4, g5, g8, h4, h7, h9.

• Brand Name: EQUINOXE
• Type of Device: GLENOID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9207608
• MDR Text Key: 162873372
• Report Number: 1038671-2019-00521
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

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: 10/03/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 02/27/2020
• 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: 59