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Catalog Number 71645070
Device Problems Failure To Adhere Or Bond (1031); Loose or Intermittent Connection (1371); Nonstandard Device (1420); Device Markings/Labelling Problem (2911); Device Operates Differently Than Expected (2913)
Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Erythema (1840); Fatigue (1849); Unspecified Infection (1930); Pain (1994); Swelling (2091); Toxicity (2333); Malaise (2359); Post Operative Wound Infection (2446); Diminished Pulse Pressure (2606); Osteopenia/ Osteoporosis (2651)
Event Date 10/14/2014
Event Type  Injury  
Event Description
Procedure performed by (b)(6) dpm at (b)(6) medical center, ankle joint and subtalar joint fusion in right lower extremity with utilization of a smith and nephew hindfoot fusion nail via standard ao fixation technique as well as synthes 4. 0 cannulated screw in the medical malleolus. The nail used had been recalled on april 22, 2008. Nails were also recalled on may 20, 2014 and july 2, 2014. I returned to the hospital on (b)(6) 2015, (b)(6) 2015 with a superficial abscess (incision open) and sent home on antibiotics. Admitted in the hospital on (b)(6) 2015 because of infection. On (b)(6) 2015, (b)(6) dpm, performed another surgical procedure. An incision was made with #15 blade and deepened via blunt dissection all the way down to the lateral cortex of the tibia. Cultures were taken as well as bone biopsy. She was flushed with saline mixed with vancomycin followed by packing with demineralized bone matrix and vancomycin. The mri performed a few days before surgery according to radiologist, findings were consistent with osteomyelitis. Reilly consistently diagnosed my condition as reflex sympathetic dystrophy and denied any evidence of osteomyelitis, abscess or infection. Using oral antibiotics prescribed by the er in (b)(6) 2015. (b)(6) referred pt to dr. (b)(6) for a second opinion. On (b)(6) 2015, dr. (b)(6) felt the case should be seen by foot/ankle specialist since this is a complicated situation with po infection now lucency around the nail - a sign of incomplete fusion. Dr. (b)(6) referred me to (b)(6). Seen by dr. (b)(6) on (b)(6) 2015. Radiologic studies reviewed x-ray images of right ankle at (b)(6). Tibiotalocalcaneal arthrodesis with hindfoot fusion nail, appears nonunited, hardware appears loose, subtatar joint distracted. Recommended i & d and hardware removal. Obtain cultures and bone biopsy - iv antibiotics. Dr. (b)(6), md performed surgery on (b)(6) 2015. Craterization of right tibia for osteomyelitis, incision and drainage of right lateral ankle abscess, separate from hardware removal and craterization incisions. Removal of deep implants from right ankle and hindfoot with layered closure. I believe that the hardware was defective and caused severe infection in the bone. I have seen in the infectious disease clinic since (b)(6) 2015 through the present day. My next appointment with dr. (b)(6) is (b)(6) 2018. I was on iv infusion from (b)(6) 2015. I have taken antibiotics from (b)(6) 2015 through the present time and will have to remain on antibiotics in order to keep from getting infection in my right lower leg and ankle. If it becomes infected again, i will lose my leg from below the knee down. On (b)(6) 2015, placement of a dual-lumen power picc line in the right basilic vein under limited c-arm x-ray. Pt in need of central venous access. Pathology diagnosis ankle, right, orthopedic hardware removal: gross description: received labeled ("old hardware") is a 15. 8 cm in length by 0. 9 cm in length purple metallic rod with a serial number which is not legible. Also included are 4 yellow metallic screws ranging in length from 2. 9 cm up to 7. 4 cm and measuring 0. 4 cm in diameter. On (b)(6) 2015 appointment with dr. (b)(6), md for removal of sutures, placed back in a cast and x-rays. Also on the same day, and appt with dr. (b)(6), md, cultures obtained and revealed coagulase negative staphylococcus. Osteomyelitis right ankle and leg. Placed on iv infusion antibiotic cefazolin and erythromycin. On (b)(6) 2015 appt with dr. (b)(6), md, no sign of infection, ankle swelling diffusely, ttp throughout. X-rays show maintained alignment. Evidence of maintained subtalar and tibiotalar joints. No surgery for arthrodesis until infection cleared by infectious disease clinic. On (b)(6) 2015 with dr. (b)(6), md ortho planning to remove the remaining screw out of medial ankle. The joint if not intact and needs reconstruction, won't happen until dr. (b)(6) with the infectious disease clinic gives dr. (b)(6) the okay to reconstruct the right ankle and foot. On (b)(6) 2015, dr. (b)(6) from status post distal fibular osteotomy and screw fixation of medial malleolus. Incomplete fusion across the tibiotalar and subtalar joints in this pt with prior hindfoot arthrodesis moderate midfoot degenerative change, osteopenia, plantar calcaneal enthesophyte. Still on antibiotics. Will returned to operating room for hardware removal right ankle. On (b)(6) 2015 back to dr. (b)(6)'s id clinic for osteomyelitis of the right ankle. Ortho planning to remove remaining screw out of medial ankle. Remains on keflex. Labs: esr improved in (b)(6) but crp elevated again. Date of surgery (b)(6) 2015 painful hardware, right ankle. Removal of deep implant from right ankle with layered closure. Pt had a medial malleolar screw placed by dr. (b)(6) that was done on (b)(6) 2014. On (b)(6) 2015, dr. (b)(6) post-op exam right ankle hardware - history of failed ankle fusion at osh complicated by osteomyelitis. Six weeks of iv abx and two months of abx, id is following along and will reassess in one month to determine if pt has cleared infection. If that is the case, she may undergo revision ankle fusion. On (b)(6) 2015, dr. (b)(6)'s id f/u clinic for osteomyelitis of right leg. Stopped antibiotics as all hardware had been removed and she is awaiting fusion. Labs - no evidence of ongoing infection - ok for ankle surgery from id standpoint. On (b)(6) 2015, dr. (b)(6) previously taken to the operating room for removal of an infected hindfoot fusion nail. Has been through iv and oral antibiotics, reports that she has been cleared for revision ankle and subtalar fusion by id. Special investigations: review of diagnostic tests, radiologic studies: i have personally reviewed plain x-ray images from (b)(6) (prior films demonstrating ankle and subtalar nonunions). Plan: to operating room for right ankle and subtalar fusions. Will plan to go through the lateral and plantar heel incisions and use a hindfoot fusion nail, along with allogenix plus case request operating room: arthrodesis ankle, arthrodesis subtalar. On (b)(6) 2015, dr. (b)(6) - surgery: right ankle arthrodesis, right subtalar joint arthrodesis. Components used: smith and nephew 10mm x 20cm hindfoot fusion nail with 5mm interlocking screws. Biologics used: allogenic demineralized bone matrix plus. On (b)(6) 2015, dr. (b)(6) for x-rays and cast removal post op. On (b)(6) 2016, dr. (b)(6) - tenderness in the lateral malleolus wound breakdown with minimal serious drainage from bottom of incision. Minimal surrounding erythema reassess wound in one week, short leg cast, continue no weight bearing. On (b)(6) 2016, dr. (b)(6), wound check, status post right ankle fusion with post operative wound infection, return to id clinic for wound check. Infected hardware in right lower extremity, cast removal, subsequent encounter (hcc). Plan: thoroughly discussed options with pt including continuing antibiotics and go ahead with surgical debridement, removing one interlocking screw wound clinic for continuing assessment before and after surgery. Return in 3 days on (b)(6) 2016 for surgery. On (b)(6) 2016 - date of surgery, preoperative diagnosis: right lateral ankle deep abscess; status post right ankle and subtalar fusion for arthrodesis of the right ankle and right subtalar joint. Post operative diagnoses: same as preoperative diagnoses. Surgeries performed: incision and drainage of right ankle deep abscess; removal of deep implant from right hindfoot, calcaneus, with layered closure. Back to operating room for revision ankle and subtalar fusion with a new hindfoot fusion nail, but developed a small abscess along the lateral ankle incision. Description of procedure: made a direct lateral incision through her previous surgical incision wound and carried this deep to the fascia. We did encounter amount a small amount of purulent fluid and obtained two sets of cultures which we sent to the microbiology lab. We then proceeded to thoroughly evacuate the depths of the wound then further debrided the depths of the wound with a small sharp curettes. We did not notice any tracking of infection anteriorly or posteriorly or distally or proximally to the wound. We then identified the transverse calcaneal screw and, as this was at the site of infection, we proceeded to close and apply prevena wound management dressing. This was hooked up to a suction and an excellent vacuum seal was noted. On (b)(6) 2016, (b)(6), pa-c for removal of vac. Placed in short leg splint with stirrups well padded with xeroform over incision, non weight bearing. On (b)(6) 2016, dr. (b)(6) - pt seen in the id clinic f/u for osteomyelitis, prior to this episode pt had cons grow from wound. Pt was placed on clindamycin one week prior to surgery. Positive for malaise/fatigue, infected hardware in right lower extremity, oral antibiotic - id clinic placed her on cipro 750mg and clindamycin 300mg. On (b)(6) 2016, dr. (b)(6) for right ankle, amount of drainage, right foot purplish in color - faint pedal pulse. Mri ordered today. Infected hardware of right lower extremity osteomyelitis, return in 3 weeks. On (b)(6) 2016, dr. (b)(6)'s id clinic, f/u for chronic osteomyelitis right ankle. Increased pain and drainage from right ankle wound. Mri showed enhancing fluid collection and waiting ortho f/u. Meds - cipro and clindamycin. On (b)(6) 2016, dr. (b)(6) re-evaluation of pt's right lateral ankle wound, continued wound drainage and severe pain. Mri small fluid collection laterally within the hindfoot. Ortho exam: erythema at distal aspect of the incision and purulence from a small area of fluctuance distally osteomyelitis. On (b)(6) 2016, operating room for irrigation and debridement lower extremity. Right ankle incision and drainage right lateral hindfoot abscess - f/u two weeks post op. On (b)(6) 2016, dr. (b)(6) - wound check and cast. No weight bearing. Continued cipro and clindamycin per id. On (b)(6) 2016 with dr. (b)(6) id clinic f/u for right ankle osteomyelitis. Picc line on (b)(6) 2016 for iv infusion. F/u with dr. (b)(6) in 2 weeks for wound check. F/u with dr. (b)(6) on (b)(6) 2016 noted incision was healing, no sign of infection and f/u in six weeks for x-rays, continue abx per id clinic. On (b)(6) 2016 f/u with dr. (b)(6) for osteomyelitis and for (b)(6) 2016 for debridement of abscess, started empirically on vancomycin and ertapenem. Pt had some yellow drainage from superior aspect of incision. Still continuing with dr. (b)(6). Followed up with dr. (b)(6) on (b)(6) 2016 for x-rays, incision was healed. No sign on infection, f/u in two months for x-rays. Picc line was removed at the end of (b)(6) 2016 and pt is continuing on oral antibiotics. Almost lost leg from the knee down. I feel this was due to defective hardware, nails and screws. Seven surgeries in all. Iv infusions. Still on oral antibiotics. There is still the possibility of losing the lower part of right leg if infection occurs again. I feel smith and nephew has a major problem with their trigen hindfoot fusion nail and screws.
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Manufacturer (Section D)
1450 e. brooks rd.
memphis TN 38116 1804
MDR Report Key6983315
MDR Text Key90644319
Report NumberMW5072995
Device Sequence Number0
Product Code HSB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/13/2017
9 Devices were Involved in the Event: 1   2   3   4   5   6   7   8   9  
1 Patient was Involved in the Event
Date FDA Received10/27/2017
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71645070
Device Lot Number14CM16232
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/27/2017 Patient Sequence Number: 1