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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOPRO, INC. BIOPRO IMPLANT RIGHT HALLUX AND LONG ARM AUSTIN WITH INTERNAL FIXATION RIGHT FOO; PROTHESIS, TOE, HEMI-PHALANGEAL
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BIOPRO, INC. BIOPRO IMPLANT RIGHT HALLUX AND LONG ARM AUSTIN WITH INTERNAL FIXATION RIGHT FOO; PROTHESIS, TOE, HEMI-PHALANGEAL Back to Search Results
Lot Number 116620
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Pain (1994); Joint Swelling (2356); Impaired Healing (2378)
Event Date 10/09/2015
Event Type  Injury  
Event Description
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.
 
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Brand Name
BIOPRO IMPLANT RIGHT HALLUX AND LONG ARM AUSTIN WITH INTERNAL FIXATION RIGHT FOO
Type of Device
PROTHESIS, TOE, HEMI-PHALANGEAL
Manufacturer (Section D)
BIOPRO, INC.
MDR Report Key8124666
MDR Text Key129310110
Report NumberMW5081760
Device Sequence Number1
Product Code KWD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Lot Number116620
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/30/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age58 YR
Patient Weight79
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