MAUDE Adverse Event Report: EXACTECH, INC. NOVATION CERAMIC LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number NOVATION CERAMIC LINER

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that "one patient that participated in this study, whose 10 yr date has lapsed, should have been completed 2018.However, according to her records, approx.1 yr later (2019), she broke her ceramic prosthesis and underwent a hip revision (b)(6) 2019.She has continued to have difficulty with postoperative infections as well as developed left foot pain.She was recently diagnosed with (b)(6) and was referred to a specialist for treatment in (b)(6) 2020.No further information known at this time.

Manufacturer Narrative

(h3) the revision reported was likely the result of ceramic liner fracture.The root cause for the liner fracture could not be determined as the devices and x-rays were not available for evaluation and detailed information regarding the fracture was not provided.The most probable root cause associated with the reported event of "ceramic liner cracked or broken¿ is associated with a partial or full-thickness crack in a ceramic liner device either during implantation or post-operatively.

• Brand Name: NOVATION CERAMIC LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12360214
• MDR Text Key: 267893805
• Report Number: 1038671-2021-00410
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOVATION CERAMIC LINER
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 03/11/2022
• Supplement Dates FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female