MAUDE Adverse Event Report: EXACTECH, INC. NOVATION CROWN CUP ACETABULAR SHELL

Catalog Number 186-01-52

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 10/09/2014

Event Type  Injury  

Event Description

Patient has superficial infection.Surgeon cleaned out the region of the incision.No reported revision or issue with implants.

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Review of the device history record showed that the named devices were accepted with conformance to the device requirements.

• Brand Name: NOVATION CROWN CUP ACETABULAR SHELL
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): EXACTECH, INC.; 2320 n.w. 66th ct.; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 n.w. 66th ct.; gainesville, FL 32653
• MDR Report Key: 4356570
• MDR Text Key: 5114958
• Report Number: 1038671-2014-00651
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2014

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: 186-01-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/16/2014
• 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