MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; NOVATION CROWN CUP CLUSTER HOLE 50MM GROUP 1

Model Number 180-01-50

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

Patient Problem Failure of Implant (1924)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

Pending engineering evaluation.Concomitant medical products: cocr femoral head 32mm +3.5 offset (cn: 142-32-03, sn: (b)(4); nv gxl liner 10o 32mm (cn: 138-32-51, sn: (b)(4); screw 30mm 6.5 (cn: 120-65-30, sn: (b)(4); c-series 2nd offset 12/14 size 1 (cn: 116-30-01, sn: (b)(4).

Event Description

Original right total hip arthroplasty was performed on this female patient on (b)(6) 2009.The surgeon brought the patient in because their acetabular cup and liner were spun out and loose when he looked at their x-ray.The surgeon opened the joint in standard fashion.The surgeon decided to pull everything out and implant stryker femoral components and acetabular components.The patient left the operating room in stable condition and is expected to have a good outcome.There was no delay to the surgery.The rep was present at the time of the surgery.The hospital did not release implants to be returned to exactech.

Manufacturer Narrative

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) loosening of the acetabular cup.However, this cannot be confirmed since the devices were not returned for evaluation.(d11) concomitant device(s): cocr femoral head 32mm +3.5 offset (cn:(b)(4), sn: (b)(6).Nv gxl liner 10o 32mm (cn:(b)(4), sn: (b)(6).Screw 30mm 6.5 (cn:(b)(4), sn: (b)(6).C-series 2nd offset 12/14 size 1 (cn:(b)(4), sn: (b)(6).

• Brand Name: NOVATION
• Type of Device: NOVATION CROWN CUP CLUSTER HOLE 50MM GROUP 1
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9139393
• MDR Text Key: 166928770
• Report Number: 1038671-2019-00475
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862037008
• UDI-Public: 10885862037008
• 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: 04/15/2020

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: 01/13/2014
• Device Model Number: 180-01-50
• Device Catalogue Number: 180-01-50
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR