MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS TOE IMPLANT-UNSPECIFIED; N/A

Catalog Number XXX-TOE IMPLANT

Device Problems Break (1069); Crack (1135); Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Disability (2371); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported a toe implant was explanted.It was reported the implant was damaged.The surgeon who implanted the device (1st surgeon) reported he had performed a toe implant in the past.A different surgeon (2nd surgeon) had apparently taken the implant out and given it to the patient to take back to the original surgeon.The 2nd surgeon stated the implant was damaged.Additional information was received.The device is a futura (fgt) toe implant; silicone, not metal.It is believed the device was removed and then the other surgeon fused the toe.The patient was female.Several months ago the patient came in to see the surgeon who implanted the device (1st surgeon).She had the explanted implant with her.The 1st surgeon noted the device was not completely broken in half, it was fractured, it had a crack in it.It was unclear when the damage occurred ¿ while implanted or during removal.The 1st surgeon discussed the situation with the distributor and the integra regional mgr.The surgeon wanted to know if it was possible to identify the fracture of the implant via imaging studies (while implanted).Additional information was received from the surgeon (1st surgeon).The surgeon stated he believed this was a fraudulent episode.¿the fgt flexible implant was implanted on (b)(6) 2014.This was a workman¿s comp claim.The patient is a maintenance worker ¿ on his feet a lot doing mechanical work.His recovery was longer than usual but he returned to work.In (b)(6) 2016 ¿ the patient saw a podiatrist, for an independent review (related to the workman¿s comp claim).The podiatrist told the patient the implant was broken and the issue required another surgery.The podiatrist referred the patient to another surgeon, the surgeon who removed the device and fused the joint in (b)(6) 2016 (2nd surgeon).The patient returned to 1st surgeon in (b)(6) 2016 ¿ frustrated, complaining of continuous pain, difficulty walking and still wearing a boot.He showed the 1st surgeon the removed implant.The 1st surgeon reported, ¿there was a cut in the stem of the implant.This would not happen from wear.The implant would still function with this type of cut.The patient went from fully functional to disabled following the 2nd surgery.I¿m not convinced the cut in the stem is a defect.¿ the 1st surgeon stated, ¿i am a very experienced user of this product.I perform about a half dozen of these procedures yearly for the past 20 years.¿.

Manufacturer Narrative

Integra has completed their internal investigation on 6dec2016.The investigation activities included: methods: -review of device history records.- review of complaint management database for similar complaints.Results: no size or lot information was provided, so a review of the dhr cannot be conducted.A review of the complaints in trackwise found no other complaints reported for a similar event.This does not represent an adverse trend.Conclusion: as the product in question was not returned for examination, and the alleged failure mode is not clear, no root cause could be established.

• Brand Name: TOE IMPLANT-UNSPECIFIED
• Type of Device: N/A
• 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: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6124611
• MDR Text Key: 60791150
• Report Number: 1651501-2016-00044
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• PMA/PMN Number: K023086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-TOE IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention