MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. ACCUFILL 5CC; CALCIUM PHOSPHATE COMPOUND BONE SUBSTITUTE MATERIAL

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient is a (b)(6) year old male history of previous ankle arthroscopy and constant pain.The patient was treated by dr.(b)(6), dpm.Below is dr.(b)(6) description of the patients condition: i got an mri pretty negative besides mild bone marrow edema along the stj joint.Then i got a ct scan in 1/16 showed an incomplete fx of posterior talus, not big out to warrant orif.I tried conservative treatment with patient for over 1 year, then using accufil by zimmer (subchondroplasty) in (b)(6) 2016, incision over lateral process of talus.He didn't do well after surgery was in severe pain and developed localized infection with wound dehiscence from a 5mm incision, but had constant drainage.Went to wound care and om of talus with wound probe to bone.Was in 6 weeks iv cefepime developed leukopenia then was switched to oral cipro.Wound healed but constant edema with pain.I decided to take him back 2 months later to open up the wound.The graft never took was black/necrotic.Took out all the graft, all cultures and bone biopsy negative, bone, soft tissue and deep swabs.Could be cause of the antibiotics.I used antibiotic bead which i saw in images 2 months later that never took.Then used serial applications of amniotic umbilical cord graft to close the wound with wound vac.As soon as the vac would be taken off he would start draining with regression of wound.I did further imaging.Mri on both t1 and t2 have decreased uptake, looks like avn.I got spect bone scan, spect ct and ceretec.1/3 of the talus looks necrotic.In the spect ct looked like small air bubbles in talus.Ceretec shows more involvement in soft tissue with mild involvement of talus.I took him back to or two weeks ago after seeing ceretec to take out wound further wash out with taking out some bone not being too aggressive bc he is getting married this month.He recently revealed to me he is impotent for the past 1 year, maybe small vessel disease? then while admitted elevated bs, 2 years ago had elevated sugar levels was controlled with diet.Which was consistently elevated this admission and now with endocrinologist for type ii dm.He aspirated vomit at night but then had symptoms of double vision and palpitations cta was ordered positive for infiltrates in lung.Will get cta in 3 months to see if still there.Current bone biops and c&s from past 2 weeks all negative.Back on 6 weeks iv antibiotics with vanco and aztreonam.I packed antibiotics beads with gentamycin.The patient is not a smoker, currently he is on pain management and controlled with cymbalta alone rarely takes a percocet.A local sales representative, (b)(6), was present during the initial accufill injection case.He recalls 1-2 ccs of material being injected at most and recalls it being very difficult to get the accuport in and to inject the accufill.At the time of this investigation, operative notes and imaging were not available for review, so proper placement of the accufill material cannot be confirmed.It is unknown whether failure of the accufill material to incorporate was related to the local infection, systemic conditions, improper technique or other factors.

Event Description

Patient in pain.

• Brand Name: ACCUFILL 5CC
• Type of Device: CALCIUM PHOSPHATE COMPOUND BONE SUBSTITUTE MATERIAL
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer Contact: victor krone ; 841 springdale drive; exton, PA 19341 ; 4848794224
• MDR Report Key: 6109312
• MDR Text Key: 60125540
• Report Number: 3008812173-2016-00026
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2016

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ACCUFILL
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 11/17/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR