MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM, PRIMARY, PRESS-FIT

Catalog Number 300-01-15

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Disorder (2373); Joint Dislocation (2374)

Event Date 03/21/2017

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) 2016.Non-revision of right shoulder components due to dislocation while patient was hugging his wife.Relocated in office under fluoro and placed in external rotation sling for 4 weeks.

Event Description

No additional information provided.This is one of six products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00242, 1038671-2017-00243, 1038671-2017-00244, 1038671-2017-00245 and 1038671-2017-00246.

Manufacturer Narrative

In a review of the labeling it is a known complication that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.Revisions or surgical interventions are a known complication found in joint replacements.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 dislocation of the right shoulder joint devices is most likely related to over activity and patient underlying conditions to include previous shoulder maladies.This device is used for treatment, not diagnosis.

• Brand Name: EQUINOXE HUMERAL STEM, PRIMARY, PRESS-FIT
• Type of Device: HUMERAL STEM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6516170
• MDR Text Key: 73730375
• Report Number: 1038671-2017-00241
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 300-01-15
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/24/2017
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 79