MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. MGT MOVEMENT METATARSAL SZ. 20; MOVEMENT GREAT TOE

Catalog Number MGT-890-20MT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Malaise (2359)

Event Type  Injury  

Event Description

It was reported the pt was complaining of systemic problems and believes her fatigue, malaise and hypersensitivity over her entire body are due to the metal in the device implant placed in her great toe on (b)(6) 2014.It was reported the surgeon is looking for info history of other similar cases, evidence the device does not cause these issues and agreement/confirmation that an allergic reaction would be localized to the great toe area.Add'l info has been requested.Add'l info rec'd on 5feb2015: rec'd a phone call from the reporter of the complaint.She and the physician believe the pt thinks her toe implant will have similar problems with metal-to-metal hip implants.She wants to explore if there are metal ions in her blood stream causing systemic problems.The physician is sending the pt for a second opinion and recommended she go for environmental testing.(b)(6) wants to know when the integra champion conversation with dr (b)(6) occurs.Device remains implanted.More add'l info rec'd via email 5feb15: i just heard back from the physician.He stated that the pt has been diagnosed with idiopathic environmental intolerance (aka multiple chemical sensitivity); this is new since surgery.She is unable to work and now has a new sensitivity to fragrances and headaches - this is what she is calling whole body allergic reaction.She is also having typical pain, stiffness and swelling in the joint.She is being referred to another physician who uses these implants.

Manufacturer Narrative

The device will not be returned since it remains implanted.Based on reported info, integra has initiated an investigation.

• Brand Name: MGT MOVEMENT METATARSAL SZ. 20
• Type of Device: MOVEMENT GREAT TOE
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; austin TX
• Manufacturer Contact: maria leonard ; 311 enterprise dr; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4510163
• MDR Text Key: 5487426
• Report Number: 1651501-2015-00004
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• PMA/PMN Number: K102549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MGT-890-20MT
• Device Lot Number: 13-0403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2015
• 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 Outcome(s): Other