MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 11

Model Number	164-01-11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation noted that based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the revision is most likely is related to patient conditions.
Event or Problem Description
Approximately 4.5 years postop the initial tha, this female patient had been dislocating the right hip and the surgeon felt the stem was too anteverted.The liner was removed and replaced with a hooded liner and the femoral head was exchanged for a competitor¿s head (modular head system allowing version adjustments).Patient was last known to be in stable condition following the event.Devices will not return due to rep not present due to covid policy.

• Brand Name: NOVATION
• Common Device Name: ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 11
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10419834
• Report Number: 1038671-2020-00491
• Device Sequence Number: 3190316
• Product Code: MEH
• UDI-Device Identifier: 10885862035097
• UDI-Public: 10885862035097
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2020
• Device Model Number: 164-01-11
• Device Catalogue Number: 164-01-11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention