MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS INTEGRA XT, TIBIAL IMPACTOR; ORTHOPEDIC ANKLE

Catalog Number MJU937T

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.As such, a failure analysis could not be conducted.A review of the lot records was conducted, and did not discover any indication of problems that could have caused or contributed to the complaint.The reported complaint was not confirmed.Thus, a possible root cause could not be found.

Event Description

A sales representative reported that the patient had a taa surgery with an unknown device implanted and an unknown date.On (b)(6) 2018 a revision surgery was done due to a failed taa.Per sales representative: ¿the surgeon had difficulties of inserting the integra xt revision finned tibial tray started after making the anterior tibial window.At this point another 20 mm needs to be removed from the intramedullary canal of the tibia.We provide a curette, but this is a straight curette and the approach angle prevents getting to the anterior portion of the canal.The doctor suggested an angled curettes, or a right angle type of curette to scrap the anterior portion.He then inserted the tibial tray, which he said this part was smooth, but he was left with an uniform gap of 10 mm parallel to the tibial resection.As intended, he used the tibial impactor to close the gap.This is the main issue he faced.The angle of the tibial impactor is 18° off vertical and the forefoot is in the way.In the validation lab we were able to internally rotate and plantar flex the foot out of the way, but this was for healthy and flexible specimens.In a revision case, the patient¿s foot can easily be stiff and the bone can be sclerotic.The doctor spent an hour trying to get the implant in.He could not use the impactor in any method and finally used a cobb to get the implant in position.He suggested an impactor design like an acetabular cup impactor.The cobb obviously scratched the implant, but this seemed to be his only option.The poly did lock in place properly, and he was extremely happy with the end result.¿ the event caused the surgery to take approximately one hour longer than it otherwise would have.This was a staged revision ¿ the only thing explanted during this procedure was a cement spacer.

• Brand Name: INTEGRA XT, TIBIAL IMPACTOR
• Type of Device: ORTHOPEDIC ANKLE
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8574974
• MDR Text Key: 147620484
• Report Number: 1651501-2019-00016
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K182878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: MJU937T
• Device Lot Number: 234121-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR