MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA)

Catalog Number	310-01-44
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: 300-10-45, (b)(4), anatomic replicator plate 4.5mm, 300-20-02, (b)(4), torque defining screw kit.
Event or Problem Description
It was reported that about 18 months ago, this female patient received a right total shoulder prosthesis.The patient presented at the physician¿s office with a painful total shoulder and no sign of infection.Upon review of x-ray, it was determined the humeral head (size 44 short) was overstuffing the joint.Lab work confirmed there was no signs of infection.The surgeon¿s plan was to revise by downsizing the head to a 38mm short.Reportedly, there were no complications and the patient was stable leaving or.The removed devices are not being returned to the manufacturer per hospital protocol.No further information available is at this time.
Additional Manufacturer Narrative
Section h10: (d4) expiration date: 12-apr-2027; (g5) pma/510(k)number: k042021; (h3) the revision reported was likely the result of pain.(h5) device manufacture date: 12-apr-2017.According the information provided, ¿upon review of x-ray it was determined the humeral head (size 44 short) was overstuffing the joint.Surgeon chose to revise by downsizing the head to a 38mm short.¿ a review of the dhr and/or the sterilization records was not conducted because the event as described does not appear to be related to the design, manufacturing, or reasonably foreseeable misuse of the device.Intractable pain is listed in the total joint surgery risks section of the equinoxe shoulder system ifu 700-096-060 rev m.

• Brand Name: EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA)
• Common Device Name: HUMERAL HEAD SHORT, 44MM (ALPHA)
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8841337
• Report Number: 1038671-2019-00380
• Device Sequence Number: 226551
• Product Code: KWT
• UDI-Device Identifier: 10885862083876
• UDI-Public: 10885862083876
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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 Catalogue Number: 310-01-44
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention