MAUDE Adverse Event Report: ETHICON INC. BONE WAX; WAX, BONE

Catalog Number BONEWAXUNK

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No specific patient information regarding events has been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products / bone wax involved caused and /or contributed to the adverse events described in the article, specifically: adhesions, foreign body reaction, inflammation? if yes, provide details of event and specific suture product type.Can specific patient demographics be provided for each of the subjects of this article? if yes, please include:.

Event Description

It was reported in a journal article that the patient underwent femoral acetabular impingement surgery on an unknown date and bone wax was used.During revision procedure, the patient possibly experienced foreign body-type chronic synovial inflammation, lymphoplasmacytic inflammatory reaction.It was also reported that the patient may have experienced capsular adhesions and possible additional disorders.Additional information has been requested.

• Brand Name: BONE WAX
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.; rodovia presidente dutra; km 154; sao paolo ; BR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6820810
• MDR Text Key: 83654579
• Report Number: 2210968-2017-70076
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BONEWAXUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2017
• 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 Outcome(s): Required Intervention