MAUDE Adverse Event Report: EXACTECH, INC. NOVATION ELEMENT RO X/O SZ 11; SEE H10

Model Number 164-12-11

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Date 02/20/2023

Event Type  Injury  

Event Description

It was reported via legal documentation that this patient had an initial left total hip arthroplasty on (b)(6) 2016 and then approximately 6 years, 4 months later experience a revision surgical procedure on (b)(6) 2023.Revision operative report of (b)(6) 2023.Postoperative diagnosis: left total hip arthroplasty loosening.Abductor tendon repair.Visit diagnosis: loosening of femoral component of prosthetic left hip.Patient revised to competitor¿s devices.Indication: patient had pain that never resolved.Work up was consistent with acetabular loosening.Procedure: the explant system was used to remove the acetabular component with minimal bone loss.Sterile compressive dressings were applied.The patient was awakened and taken to recovery room in satisfactory condition.There were no complications.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.

Manufacturer Narrative

D2b: prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate.D10.Concomitants: (b)(6), 130-36-53 - nv gxl linr, ntrl, 36mm id, group 3 cups; (b)(6), 170-36-93 - biolox delta femoral head 36mm od, -3.5mm; (b)(6), 180-65-25 - alteon 6.5mm screw, 25mm; (b)(6), 186-03-56 - integrip mh cup sz 56mm.Pending investigation.There is no other information available.

• Brand Name: NOVATION ELEMENT RO X/O SZ 11
• Type of Device: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17190239
• MDR Text Key: 317746197
• Report Number: 1038671-2023-01446
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10885862202642
• UDI-Public: 10885862202642
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: 164-12-11
• Device Catalogue Number: 164-12-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Date Device Manufactured: 05/02/2016
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female