MAUDE Adverse Event Report: EXACTECH, INC. NOVATION CERAMIC AHS; NV AHS CERAMIC LINER GROUP 3

Catalog Number 140-36-13

Device Problems Break (1069); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical devices: novation ahs cluster cup, 54mm, group 3 (cn: 140-01-54, sn: (b)(4)).Biolox femoral head 12/14, 36mm, 3.5+ (cn: 140-36-03, sn: (b)(4)).

Event Description

(b)(6) of 2018 a traumatic event occurred, resulting in squeaking.Early (b)(6) 2019 patient returned with broken ceramic liner.Revised (b)(6) 2019 patient was stable and doing well upon leaving operating room.

Manufacturer Narrative

Section h10: (h3) the evaluation noted in the revision reported was likely the result of a fractured ceramic liner.This may have been due to the patient¿s reported bmi of 64 (extremely obese) and/or their reported traumatic event which could have affected the positioning of the liner and/or damaged the liner leading to the audible squeaking and subsequent fracture.However, this cannot be confirmed because the component was not returned for evaluation and x-rays were not provided.(d11) concomitant devices: 1.Novation ahs cluster cup, 54mm, group 3 (cn: 140-01-54, sn: (b)(6)) 2.Biolox femoral head 12/14, 36mm, 3.5+ (cn: 140-36-03, sn: (b)(6)).

• Brand Name: NOVATION CERAMIC AHS
• Type of Device: NV AHS CERAMIC LINER GROUP 3
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8655562
• MDR Text Key: 146622365
• Report Number: 1038671-2019-00305
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: P050039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

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: 03/20/2017
• Device Catalogue Number: 140-36-13
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 09/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR