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

Model Number 320-36-00

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

Patient Problem Failure of Implant (1924)

Event Date 11/28/2022

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, approximately 9 months post op the initial reverse tsa, this 83 y/o female patient developed pain over the last two weeks.Whenever she got in and out of van, she had to pull herself up to the seats using the right hand multiple times.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.Action taken: apply ice and heat packs.The outcome is continuing.No additional information.

Manufacturer Narrative

Device evaluated by mfr: 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 the shoulder pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition [pulling with her arm on the replacement side] that impacts the performance of the device.It is well known that excessive activity and trauma affect joint replacements.Concomitant medical products: 300-01-10 - equinoxe humeral stem primary press fit 10mm, 320-10-00 - equinoxe reverse tray adapter plate tray +0, 320-31-36 - glenosphere, 36mm, 320-35-01 - small glenoid plate.

• 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, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16029002
• MDR Text Key: 305943993
• Report Number: 1038671-2022-01619
• Device Sequence Number: 1
• Product Code: KWT
• 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
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-36-00
• Device Catalogue Number: 320-36-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 38 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White