MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE REVERSE HUMERAL LINER

Catalog Number 320-42-00

Device Problems Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.

Event Description

Index surgery: (b)(6) 2014.Revision of right shoulder components due to infection.This event report was received through clinical data collection activities.

Manufacturer Narrative

All patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery.The event of infection is greater than 3 months postop and it is highly unlikely to be related to the surgical procedure or devices.The most likely cause of the reported event is related to the underlying patient condition.This device is for treatment, not diagnosis.

Event Description

Reported on (b)(6) 2017 that the patient is doing well and the antibiotic spacer remains in place.Associated mfrs: 1038671-2017-00164, 1038671-2017-00165, 1038671-2017-00166, 1038671-2017-00167, 1038671-2017-00168, 1038671-2017-00169, 1038671-2017-00170, and 1038671-2017-00171.

• Brand Name: EQUINOXE REVERSE HUMERAL LINER
• Type of Device: HUMERAL LINER
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 6403705
• MDR Text Key: 69900577
• Report Number: 1038671-2017-00167
• Device Sequence Number: 1
• Product Code: KWT
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

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: Physician
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2017
• Initial Date FDA Received: 03/14/2017
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 72 YR
• Patient Weight: 127