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

Model Number 314-02-14

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Information (3190)

Event Date 08/08/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 300-01-09, 5241291, equinoxe, humeral stem primary, press fit 9 mm, 300-10-15, 5573988, equinoxe replicator plate 1.5 mm o/s, 300-20-02, 5631616, equinox square torque define screw drive kit, 310-01-47, 5490361, equinoxe, humeral head short, 47 mm (beta).

Event Description

It was reported an original left total shoulder arthroplasty was performed on this male patient on (b)(6) 2018 at york hospital.Patient had a failed subscapularis, and surgeon discussed converting to a reverse for better function.Patient was converted and a new stem was cemented in place.Patient left or stable and the surgeon believed there would be a successful outcome.

Manufacturer Narrative

Section h10: (h3) as reported, the left total shoulder arthroplasty was performed on this male patient on (b)(6) 2018.Patient had a failed subscapularis, and surgeon converted to a reverse for better function and a new stem was cemented in place.Patient left or stable and surgeon believed there would be a successful outcome.Explants will not be returned per hospital policy.In a review of the labeling and ifu 700-096-004 rev.N, it is a known complication that excessive activity and trauma affecting joint replacements have been associated with premature failure and may require a second surgical intervention or revision.All patients should be instructed on the limitations of the prosthesis, 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.Upon review, there is no indication that there is a device related problem, there is no allegation against the device.The most likely cause of the reported event is related to the underlying patient condition.Section h11: corrections made in the following section(s): (b5) as reported, the left total shoulder arthroplasty was performed on this male patient on (b)(6) 2018.Patient had a failed subscapularis, and surgeon converted to a reverse for better function and a new stem was cemented in place.Patient left or stable and surgeon believed there would be a successful outcome.Explants will not be returned per hospital policy.

Event Description

As reported, the left total shoulder arthroplasty was performed on this male patient on (b)(6) 2018.Patient had a failed subscapularis, and surgeon converted to a reverse for better function and a new stem was cemented in place.Patient left or stable and surgeon believed there would be a successful outcome.Explants will not be returned per hospital policy.

• Brand Name: EQUINOXE
• Type of Device: GLENOID, PEGGED BETA, LARGE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9152293
• MDR Text Key: 166750694
• Report Number: 1038671-2019-00481
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862084521
• UDI-Public: 10885862084521
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: 314-02-14
• Device Catalogue Number: 314-02-14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR