MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-02-10 for MGT MOVEMENT PROX PHAL TOTAL SZ 20 MGT-890-20PPT manufactured by Ascension Orthopedics, Inc..
[21726806]
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 of 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 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 as 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)(4) wants to know when the (b)(4) 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 adn swelling in the joint. She is being referred to another physician who uses these implants.
Patient Sequence No: 1, Text Type: D, B5
[21851016]
The device will not be returned since it remains implanted. Based on reported info, integra has initiated an investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2015-00003 |
| MDR Report Key | 4510153 |
| Report Source | 05,07 |
| Date Received | 2015-02-10 |
| Date of Report | 2015-01-15 |
| Date Mfgr Received | 2015-01-15 |
| Date Added to Maude | 2015-02-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MGT MOVEMENT PROX PHAL TOTAL SZ 20 |
| Generic Name | MOVEMENT GREAT TOE |
| Product Code | LZJ |
| Date Received | 2015-02-10 |
| Catalog Number | MGT-890-20PPT |
| Lot Number | 13-1798 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS, INC. |
| Manufacturer Address | AUSTIN TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-10 |