MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-30 for BIOPRO IMPLANT RIGHT HALLUX AND LONG ARM AUSTIN WITH INTERNAL FIXATION RIGHT FOO manufactured by Biopro, Inc..
[129310110]
Had joint replacement surgery on my right foot big toe. Joint was removed and the procedure performed was a keller arthroplasty with biopro implant right hallux with long arm austin with internal fixation right foot. After surgery healing did not progress as expected. My conditioned worsened with continuous swelling. Physical therapy and steroids were temporarily helpful. I had to wear a shoe that was a size and a half larger than my left because of continued swelling and pain. After a year with no relief or improvement i had to have surgery to remove the implant in (b)(6) 2016. The findings of the second surgery were loose hardware. The manufacturer of the devices used were paragon for the screws 3. 0 x 16mm and 3. 0x14mm cannulated screws and biopro implant serial #(b)(4) lot #116620. I would like to know if there are any other complaints of failure or recalls on this device. I am still having issues even after removal and may have to have a 3rd surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081760 |
| MDR Report Key | 8124666 |
| Date Received | 2018-11-30 |
| Date of Report | 2018-11-29 |
| Date of Event | 2015-10-09 |
| Date Added to Maude | 2018-12-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIOPRO IMPLANT RIGHT HALLUX AND LONG ARM AUSTIN WITH INTERNAL FIXATION RIGHT FOO |
| Generic Name | PROTHESIS, TOE, HEMI-PHALANGEAL |
| Product Code | KWD |
| Date Received | 2018-11-30 |
| Lot Number | 116620 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOPRO, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-30 |