MAUDE Adverse Event Report: EXACTECH, INC. SMALL SUPERIOR AUGMENT GLENOID PLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number SMALL SUPERIOR AUGMENT GLENOID PLATE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/05/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: (b)(4), 300-01-11 - equinoxe, humeral stem primary, press fit 11mm, (b)(4), 315-35-00 - glnd kwire, (b)(4), 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(4), 320-15-05 - eq rev locking screw, (b)(4), 320-20-00 - eq reverse torque defining screw kit, (b)(4), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, (b)(4), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, (b)(4), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(4), 320-31-40 - glenosphere, 40mm, 320-40-03 humeral liner, 40mm, +2.5 7094722.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a 71 yo female patient, initial left shoulder implanted on (b)(6) 2022, with no complications, ¿post op x-rays looked perfect¿, underwent a revision procedure on (b)(6) 2022.The x-rays showed that the implant had either rotated superiorly or migrated up.The doctor removed the liner, and then removed the glenosphere and all three screws from the baseplate.He then removed the superior baseplate and found that the top 1/3 superior/posterior had fractured resulting in the baseplate migrating superior.The doctor decided to switch to a tornier baseplate and used a 39 glenosphere.On the humoral side, the stem and +0 tray were well fixed so he trailed with a 40 +2.5 liner but wanted a little more constraint so went with a 40+2.5 liner.The patient was last known to be in stable condition following the event.

Manufacturer Narrative

H6: 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 cause of surgical revision due to scapular fracture cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• Brand Name: SMALL SUPERIOR AUGMENT GLENOID PLATE
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15729741
• MDR Text Key: 303047079
• Report Number: 1038671-2022-01401
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10885862534873
• UDI-Public: 10885862534873
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SMALL SUPERIOR AUGMENT GLENOID PLATE
• Device Catalogue Number: 320-35-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female