MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-11-21 for ANATOEMIC, 18.5MM AR-9500-185 manufactured by Arthrex Inc..
[92601070]
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided. No further patient information was provided at the time of this report or made available in response to follow-up communication. No additional adverse consequences have been reported from this event. This device is used for treatment. The device was requested for evaluation but part remains in the patient and cannot be returned therefore the complainant's event could not be verified. The cause of the event could not be determined from the information available and without device evaluation. Device history record review revealed nothing relevant to this event. A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure. Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials. Patient sensitivity to materials must be considered prior to implantation. This is the first complaint of this type for this part/lot combination. The potential causes of this event are being communicated to the event reporter. If additional relevant information is received, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[92601071]
It was reported that the patient was having severe pain and swelling in her right foot and on (b)(6) 2017, an anatoemic prosthesis surgery was performed and an ar-9500-185, anatoemic prosthesis 18. 5mm was implanted (lot 1410007). Patient stated she had also had a prior bunion surgery on that same foot approximately 20 years ago. Patient states that her right foot continues to swell on a daily basis and is causing her significant pain. She is unable to wear a normal shoe due to the swelling and pain. Patient states she has no known allergies to metals but does have allergies to many antibiotics and many medications make her very ill. No infection or allergy testing has been done as of time of report. Patient has seen her surgeon, who in her opinion has been dismissing her symptoms and her. Patient was calling to inquire if arthrex could determine if the device size might have been wrong for her foot. Patient was informed that arthrex is not qualified to make that determination as only a licensed medical professional can do so. Patient was referred back to her regular surgeon or a different surgeon for a second opinion. Patient was also provided with the material composition of the device to provide if needed when obtaining a second opinion. Device is comprised of cobalt chrome follow-up investigation: arthrex device ar-9500-185 was the only implant the patient received during the (b)(6) 2017 procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2017-00446 |
| MDR Report Key | 7048078 |
| Report Source | CONSUMER |
| Date Received | 2017-11-21 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-06-14 |
| Date Mfgr Received | 2017-11-02 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2017-11-21 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VIK BAJNATH, ADVERSE EVENTS |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal | 341081945 |
| Manufacturer Phone | 8009337013 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANATOEMIC, 18.5MM |
| Generic Name | PROSTHESIS, TOE, HEMI-, PHALANGEAL |
| Product Code | KWD |
| Date Received | 2017-11-21 |
| Catalog Number | AR-9500-185 |
| Lot Number | 1410007 |
| Device Expiration Date | 2019-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-21 |