MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM

Model Number 300-01-11

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 08/21/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant devices: 320-15-01, 5965238, glenoid plate, 320-20-34, 5949998, compression screw/locking cap kit 4.5 x 34 mm screw, 320-20-30, 5948869, compression screw/locking cap kit 4.5 x 30 mm screw, 320-20-26, 5901782, compression screw/locking cap kit 4.5 x 26 mm screw, 320-20-26, 5907453, compression screw/locking cap kit 4.5 x 26 mm screw, 320-15-05, 5989476, geosphere locking screw, 320-01-38, 6054316, geosphere, 320-20-00, 6051240, fixed angle torque defining screw kit, 320-38-03, 5948324, 38 mm humeral liner, 320-10-00, 6047492, humeral adapter tray +0 mm.

Event Description

The patient was diagnosed with an infected reverse shoulder implants approximately two weeks before this event.The patient was returned to surgery where the size 11 humeral stem was cemented in place, with a 0+mm adapter tray and 38 mm 0+mm liner.The stem was removed with small difficulty and minimal damage to the proximal end of humerus.The patient had a 38 mm geosphere which came away easily following removal of screw, the surgeon noted there were signs of infection present on the geosphere and the glenoid.The glenoid was also removed with minimal damage to the glenoid as there was no bone growth around the glenoid cage.Reportedly, all the removed implants showed no signs of wear or tear and no damage was seen on the implants.The patient had a non-exactech spacer implanted to help with reducing infection.No further information available at this time.

Manufacturer Narrative

Section h10: (d6) if implanted, give date: (b)(6) 2019.(g5) pma/510(k)number: k042021.(h3) on (b)(6) 2019, the patient had an equinoxe reverse system put in at (b)(6) hospital following the removal of a previous prosthesis due to infection brand and duration of original shoulder are not known).An eqionoxe size 11 press-fit humeral stem was cemented in place, with a 0+mm adapter tray and 38mm 0+mm liner.Additionally, a 38mm glenosphere and a glenoid plate were also implanted.Two weeks the patient was admitted to lincoln hospital for revision due to infection.During that surgery, while trying to dislocate the joint, the patient suffered a distal fracture of the humerus.The revision was abandoned at that time.On (b)(6) 2019, the patient was transferred to nottingham city for revision and fixation of the fracture under the care of mr wijernata.The stem was removed with small difficulty and minimal damage to the proximal end of humerus.The 38mm glenosphere came away easily following removal of screw.The surgeon noted there were signs of infection present on the glenosphere and the glenoid.The glenoid was also removed with minimal damage to the glenoid as there was no bone growth around the glenoid cage.All the implants showed no signs of wear or tear and no damage was seen on implants.A biomet antibiotic spacer was inserted to help with the infection and the fracture was repaired with a plate and screw fixation.A review of the sterility records confirmed that the product meets all specifications for sterilization and release; zero nonconformities occurred during this irradiation run.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The most likely cause of the infection requiring revision is due to the pre-existing infection of the previous implant (brand, date and duration of implant unknown).The event is related to the patient's underlying condition.(h4) device manufacture date: 10-jun-2019.(h6) evaluation codes: 1735, 2993.*no information provided in the following section(s): a2, a3, a4, a5, b6, b7, d11, g8, h7, h9.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Type of Device: HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9072684
• MDR Text Key: 162265016
• Report Number: 1038671-2019-00461
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300-01-11
• Device Catalogue Number: 300-01-11
• 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
• Patient Outcome(s): Hospitalization; Required Intervention