MAUDE Adverse Event Report: EXACTECH, INC. 36MM HUMERAL LINER +0 UNCONSTRAINED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-36-00

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

Patient Problem Joint Dislocation (2374)

Event Date 03/15/2022

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 59-year-old black or african american male had a right tsa on (b)(6) 2021.The patient presented with dislocation on (b)(6) 2022.After his annual visit last year, the patient sustained a dislocation of the right shoulder while lifting weights in the gym that required an emergency room reduction.No action was taken and the outcome of this event is resolved on (b)(6) 2022.The case report form indicates that this event is definitely related to the device and definitely not related to the procedure.Another event involving this patient is related to and recorded on (b)(4).This event report was received through clinical data collection activities and no device return is anticipated.

Manufacturer Narrative

(d10) concomitant device(s): 300-30-06 - equinoxe preserve stem 6mm : (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0 : (b)(6).320-31-36 - glenosphere, 36mm : (b)(6).320-35-02 - small superior augment glenoid plate : 6701388.320-15-05 - eq rev locking screw : (b)(6).320-20-00 - eq reverse torque defining screw kit : (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm : (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm : (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm : (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm : s(b)(6) 110710.315-35-00 - glnd kwire : (b)(6).315-35-00 - glnd kwire : (b)(6).321-52-07 - 3.2mm drill bit sterile : (b)(6).(h3) pending evaluation.

• Brand Name: 36MM HUMERAL LINER +0 UNCONSTRAINED
• 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19214605
• MDR Text Key: 341408063
• Report Number: 1038671-2024-01014
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/30/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 320-36-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1416-2024
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Race: Black Or African American