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

Catalog Number XXX-ANKLE IMPLANT

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)

Event Date 11/14/2014

Event Type  Injury  

Manufacturer Narrative

Integra completed its internal investigation 19oct2016.The investigation included: method: - review of device history records.- review of complaint management database for similar complaints.Results: at this time, no dhr review could be conducted.At this time, no trend analysis could be conducted.The complainant did not provide any information regarding the identity of the product(s) or product family of the alleged defective device(s).Requests have been submitted to the risk management department to obtain additional information.Conclusion: a root cause could not be determined due to no product information provided.

Event Description

It was reported via a legal allegation that on (b)(6) 2014 the patient underwent left ankle reconstructive surgery.The patient suffered severe pain and contracted an infection subsequent to his ankle surgery.From (b)(6) 2014 through (b)(6) 2014, at post-operative examinations, the patient continually complained of ongoing excessive pain occurring in his left ankle.The physician and staff noted at each post-operative examination that soft tissue swelling persisted in the patient's left ankle and foot.On (b)(6) 2014, radiological images indicated a fatigue fracture of the hardware implanted in the patients left foot.The patient sought additional advice from a 2nd/different physician and was then referred to a 3rd physician/different orthopedic surgeon specialist for corrective surgery.Corrective/revision surgery took place on (b)(6) 2014.The patient underwent surgery to remove and replace ankle support hardware, treat the infection, and remove bone marrow to which the infection had spread.The patient suffered permanent disfigurement due to the removal of bone matter, extensive pain and suffering, additional surgery, and disfigurement.

• Brand Name: ANKLE 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: 6052113
• MDR Text Key: 58220110
• Report Number: 1651501-2016-00038
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-ANKLE IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2016
• 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