MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; NV CROWN CUP CLSTR HOLE 54MM GROUP 2

Model Number 180-01-54

Device Problems Loose or Intermittent Connection (1371); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Pending engineering evaluation.Concomitant device(s): novation gxl liner, 10 deg face, 36mm id, group 2 cup (cn: 138-36-52, sn: (b)(4)), cocr femeral head 36mm +3.5 offset 12/14 (cn: 142-36-03, sn: (b)(4)), bone screw 15mm (cn: 120-65-15, sn: (b)(4)), bone screw 30mm (cn: 120-65-30, sn: (b)(4)).

Event Description

Original total hip arthroplasty was performed on this female patient¿s left side.The surgeon decided to revise this patient¿s hip because the acetabular cup was loose.The surgeon made his incision in standard fashion.The surgeon then knocked off the femoral head with a bone tamp.The surgeon then removed the cup, liner and screw together because it was spun out and loose.The surgeon then reamed the acetabulum to a size that the surgeon was happy with, then implanted a stryker cup and a 12/14 exactech femoral head which achieved great stability.The surgeon then closed his incision in standard fashion.The patient left the operating room in stable condition and is expected to have a good outcome.Hospital did not release implants to be sent to exactech.

Manufacturer Narrative

Section h10: (h3) the evaluation noted that the reason for the revision reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) cup loosening.However, this cannot be confirmed as the explanted devices were not returned for evaluation.(d11) concomitant device(s): novation gxl liner, 10 deg face, 36mm id, group 2 cup (cn: (b)(4), sn: (b)(6)).Cocr femoral head 36mm +3.5 offset 12/14 (cn: (b)(4), sn: (b)(6)).Bone screw 15mm (cn: (b)(4), sn: (b)(6)).Bone screw 30mm (cn: (b)(4), sn: (b)(6)).No information provided in the following section(s): a2, a4, a5, b6, and b7.The following section(s) have additional info; g4, g7, h1, h2, h3, h6 and h7.

• Brand Name: NOVATION
• Type of Device: NV CROWN CUP CLSTR HOLE 54MM GROUP 2
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9240040
• MDR Text Key: 167634851
• Report Number: 1038671-2019-00534
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862037022
• UDI-Public: 10885862037022
• Combination Product (y/n): N
• PMA/PMN Number: K070479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2014
• Device Model Number: 180-01-54
• Device Catalogue Number: 180-01-54
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention