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

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

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

This event report was received through clinical data collection activities.Pending evaluation.

Event Description

Index surgery: (b)(6) 2015.Aseptic glenoid loosening.Loose baseplate.Minimally symptomatic until (b)(6) 2018 when he had sudden pain & decreased motion.The case report form indicates this event is possibly related to devices and possibly related to procedure.

Manufacturer Narrative

Section h10: (b3) 01-dec-2018 (e3) occupation: physician (h3) index surgery: 9/16/2015.Aseptic glenoid loosening.Loose baseplate.Minimally symptomatic until 12/2018 when he had sudden pain & decreased motion.The case report form indicates this event is possibly related to devices and possibly related to procedure.This event report was received through clinical data collection activities.The report indicates the baseplate was loose, the most likely cause of the loosening is related to the patient condition.Equinoxe is intended for individuals who have degenerative disease of the shoulder.Product was not returned.No additional information provided.Indications for use: the equinoxe shoulder system is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.Per ifu # 700-096-060 rev.M states in post op instructions: all patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery.The patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses, and follow the written instructions of the physician with respect to follow-up care and treatment.The patient should be warned against unassisted activity, particularly in lifting, and that active motion should not be initiated until recommended by the surgeon in order to ensure subscapularis healing is complete.Patients must be informed that their weight and activity level may affect the longevity of the implant.Patients should be advised to report any pain, decrease in range of motion, swelling, fever, or unusual sounds as this may indicate positional changes in the implant that could lead to premature failure.Normal wear of the implant given the state of knowledge at the time of its design cannot in any way be considered to constitute a dysfunction or deterioration in the characteristics of the implant.Failure to adhere to these recommendations will result in increased probability of poor function, loosening, wear, fracture or premature failure.No information provided in the following section(s): b6, b7, d4, d6, d7, d11, g5, g8, h4, h6, h7 section h11: corrections made in the following section(s): (e1) initial reporter should be dr.Wright (section f) please disregard f6 and f8.These were entered in error.(g1) updated contact name and address to kate jacobson (g4) initial awareness date in initial submission should have been 08-may-2019.(h5) labeled for single use should be yes.

Manufacturer Narrative

Section h10: (d6) if implanted, give date: (b)(6) 2015.(h6) evaluation codes: 1924, 4002.Section h11: *the following sections have corrected information: (h3) the glenoid loosening reported was likely the result of an insufficient bond between the glenoid baseplate and the bone, which led to aseptic (non-infected) glenoid loosening, pain, and decreased motion.However, this cannot be confirmed because the component has not been revised and, therefore, is not available for evaluation.

• Brand Name: EQUINOXE
• Type of Device: GLENOID BASEPLATE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8253441
• MDR Text Key: 133237160
• Report Number: 1038671-2019-01023
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 167