MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/06/2021

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, approximately three months post initial tsa, the 87 y/o male patient experienced a scapular spine fracture after shoulder exercises performed nearly 3 months post-op.Patient's symptoms are much improved.Event resolved by patient's using a sling, relative rest.X-rays show sufficient callous formation over fracture site.Per clinical report, the reported event is definitely related to the device and possibly related to the procedure.

Manufacturer Narrative

Section d10: concomitant products - equinoxe preserve stem 14mm ( cat# 300-30-14 / serial# (b)(6)).Glenosphere 38mm (cat# 320-06-38 / serial# (b)(6)).Eq rev glenoid plate ( cat# 320-15-01 / serial# (b)(6)).145-deg pe 38mm hum liner +2.5 ( cat# 320-38-03 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10
• Type of Device: PROSTHESIS, SHOULDER, NON-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: 17723202
• MDR Text Key: 323117343
• Report Number: 1038671-2023-02235
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086433
• UDI-Public: 10885862086433
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10
• Device Catalogue Number: 320-10-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/22/2020
• 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: 87 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: White