| Model Number NB013Z |
| Device Problem
Compatibility Problem (2960)
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| Patient Problems
Unspecified Infection (1930); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Patient Problem/Medical Problem (2688)
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| Event Date 08/20/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an issue with as enduro tibia hemi-wedge.It was reported that on (b)(6) 2019, an enduro implant was explanted due to a patient infection.Per additional information received, the incident of infection was noted prior to the revision surgery.Per additional information received, it was noted that the patient's tissue turned black, which caused tissue damage.Surgeon performed an above the knee amputation.There was an patient harm, the patient has a permanent impairment.The adverse event is filed under aag (b)(4).Associated medwatch-reports: 9610612-2019-00628 ((b)(4) nb019z), 9610612-2019-00630 ((b)(4) nr440z), 9610612-2019-00631 ((b)(4) nr868z), 9610612-2019-00632 ((b)(4) nr400z), 9610612-2019-00633 ((b)(4) nr386z), 9610612-2019-00634 ((b)(4) nx042), 9610612-2019-00635 ((b)(4) nr496z), 9610612-2019-00636 ((b)(4) nr892z), 9610612-2019-00637 ((b)(4) nb076z), 9610612-2019-00638 ((b)(4) nb048z), 9610612-2019-00639 ((b)(4) nb068z), 9610612-2019-00640 ((b)(4) nb028z).
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Manufacturer Narrative
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B section: clarification - additional information h6: patient codes.Associated medwatch-reports: 9610612-2019-00628 9610612-2019-00630 ((b)(4) nr440z) 9610612-2019-00631 ((b)(4) nr868z) 9610612-2019-00632 ((b)(4) nr400z) 9610612-2019-00633 ((b)(4) nr386z) 9610612-2019-00634 ((b)(4) nx042) 9610612-2019-00635 ((b)(4) nr496z) 9610612-2019-00636 ((b)(4) nr892z) 9610612-2019-00637 ((b)(4) nb076z) 9610612-2019-00638 ((b)(4) nb048z) 9610612-2019-00639 ((b)(4) nb068z) 9610612-2019-00640 ((b)(4) nb028z) 9610612-2019-00641 ((b)(4) nb013z).
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Event Description
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Clarification: per additional information received on 10 sep 2019 from the sales consultant: history & physical: this 51-year-old male is being admitted today to undergo an elective right above-knee amputation.The individual has been a long-standing patient of ours.He had originally undergone a right total knee arthroplasty and was doing relatively well.The patient has had several admissions this year, the first being on (b)(6) 2019 when he was admitted to the hospital with acute onset of a septic right knee arthroplasty.The patient had missed 1 week of dialysis because of a recent move and was unable to obtain transportation.As a result he subsequently underwent an aspiration of his knee.Unfortunately, within 1-2 week time, he started to develop a hot, red knee.We believe that his failed dialysis resulted in seeding of his knee.He was taken to surgery, underwent irrigation and debridement of the knee and was treated with a course of rocephin.In the postoperative setting, the patient started to develop an acute onset of incisional dehiscence.As a result he was readmitted on (b)(6) 2019, underwent a repeat intervention with allograft reconstruction of the capsule.Antibiotics were continued in the postoperative setting.The patient did well but started to develop at that time some component of medical knee discomfort.Unfortunately, the patient started to develop progressive weakness and lethargy.He subsequently was admitted on (b)(6) 2019 with a periprosthetic fracture.Unfortunately, there were issues in regards to his discharge.The patient was subsequently was transferred to a nursing facility.Apparently, a lack of attention was, unfortunately, instituted.As a result, the patient started to develop gross compromise of his incision with frank dehiscence.The patient was not seen for 2 weeks in the postoperative setting, and upon his arrival to the office, grossly compromised dressing was identified with gross sloughing of the skin and necrosis.The patient underwent a staged intervention of localized debridement, application of a wound vac, subsequent muscle flap advancement.Vac system was employed.Most recently, the individual has now started to develop a pain of 7/10.He also no longer trust the knee.Plain film radiographs demonstrate what appears to be gross loosening of the prosthetic, particularly the tibial component.Because it is hinged prosthetic with recent fracture and open reduction internal fixation, the patient is believed to be having increased pain now throughout the knee.At this point, the individual wishes to end his discomfort and instability and proceed with an above-knee amputation.Surgery (b)(6) 2019: procedure performed: 1.Explanation of hinge femoral component arthroplasty.2.Complete synovectomy, 3.Above knee amputation, right leg with a salvage procedure, proximal gastroc for flap advancement, debridement and reaming right femur with implantation of vancomycin antibiotic beads.Postoperative diagnoses: 1.Infected right total knee hinged arthroplasty.2.Septic prosthetic loosening.3.Status post-periprosthetic fracture, right tibia.4.Intractable pain.5.Chronic methicillin-resistant staphylococcus aureus infection.6.Severe atherosclerotic popliteal artery disease, severe venous insufficiency with gross venous dilation, history of known lymphedema.
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Event Description
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Additional patient details not provided.
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Manufacturer Narrative
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Associated medwatch-reports: 9610612-2019-00628 9610612-2019-00630 (400443430 nr440z) 9610612-2019-00631 (400443431 nr868z) 9610612-2019-00632 (400443432 nr400z) 9610612-2019-00633 (400443433 nr386z) 9610612-2019-00634 (400443434 nx042) 9610612-2019-00635 (400443435 nr496z) 9610612-2019-00636 (400443436 nr892z) 9610612-2019-00637 (400443437 nb076z) 9610612-2019-00638 (400443438 nb048z) 9610612-2019-00639 (400443439 nb068z) 9610612-2019-00640 (400443440 nb028z) 9610612-2019-00641 (400443441 nb013z) 1.1 device reference code nb019z device name as enduro femoral component cemented f3r serial number n/a batch number 52427040 udi device identifier n/a udi production identifier n/a basic udi-di n/a unit of use udi-di n/a manufacturing date 27.04.2018 reference code nr440z device name as femur extens.Stem 5° d20x177 cem.Less serial number n/a batch number 52171650 udi device identifier n/a udi production identifier n/a basic udi-di n/a unit of use udi-di n/a manufacturing date 27.10.2015 reference code nr868z device name as enduro femur spacer distal f3 8mm serial number n/a batch number 52186351 udi device identifier n/a udi production identifier n/a basic udi-di n/a unit of use udi-di n/a manufacturing date 24.11.2015 reference code nr400z device name as nut f/femur extens.Stem all sz.Neutr.Serial number n/a batch number 52410928 udi device identifier n/a udi production identifier n/a basic udi-di n/a unit of use udi-di n/a manufacturing date 03.05.2018 reference code nr386z device name as enduro fem.Spacer post/dist f3 4x4mm serial number n/a batch number 52041541 udi device identifier n/a udi production identifier n/a basic udi-di n/a unit of use udi-di n/a manufacturing date 27.06.2014 reference code nx042 device name patella 3-pegs p2 serial number n/a batch number 52391289 udi device identifier n/a udi production identifier n/a basic udi-di n/a unit of use udi-di n/a reference code nr496z device name as tibia offset stem d16x172 cementless serial number n/a batch number 51963725 udi device identifier n/a udi production identifier n/a basic udi-di n/a unit of use udi-di n/a manufacturing date 31.10.2013 reference code nr892z device name as enduro meniscal component f3 14mm serial number n/a batch number 52041780 udi device identifier n/a udi production identifier n/a basic udi-di n/a unit of use udi-di n/a manufacturing date 11.08.2014 reference code nb076z device name as enduro tibia hemi-wedge t3 8mm rl/lm serial number n/a batch number 51823917 udi device identifier n/a udi production identifier n/a basic udi-di n/a unit of use udi-di n/a manufacturing date 01.03.2012 reference code nb048z device name as enduro tibia hemi-wedge t2 16mm rm/ll serial number n/a batch number 52041417 udi device identifier n/a udi production identifier n/a basic udi-di n/a unit of use udi-di n/a manufacturing date 07.08.2014 reference code nb068z device name as enduro tibia hemi-wedge t3 16mm rm/ll serial number n/a batch number 52271298 udi device identifier n/a udi production identifier n/a basic udi-di n/a unit of use udi-di n/a manufacturing date 10.10.2016 reference code nb028z device name as enduro tibia hemi-wedge t1 16mm rm/ll serial number n/a batch number 52427733 udi device identifier n/a udi production identifier n/a basic udi-di n/a unit of use udi-di n/a manufacturing date 30.05.2018 the implants arrived in a contaminated condition and they are available for investigation the components were decontaminated internally according internal standards.Investigation failure description the implants arrived with adhesive bone cement.The available components shows no serious visible damage.Investigation the investigation was carried out visually and microscopically with the digital-camera "panasonic dmc tz8".We made a visual inspection of the implant.Here we found wrinkling of the bone cement and adhesive bone cement at the as tibia offset stem nz496z.Additionally we detected a visible damaged sliding surface of the tibia component nb013z.Furthermore we discovered no visible bone accrual.A groove were also found and salt residues or rinsing residues were detected.The hinge ring can be moved but shows visible damage.The femoral component nb019z shows also visible damage.Furthermore we found signs that the implant was not properly anchored in the bone.The component implant shows discolorations.Additionally the implant components were inspected visual with the head of biomechanical test laboratory.Batch history review the device quality and manufacturing history records have been checked for all the lot numbers (52427040 / 52171650 / 52186351 / 52410928 / 52041541 / 52391289 / 51963725 / 52041780 / 51823917 / 52041417 / 52271298 / 52427733 / 52215946) and found to be according to the specification, valid at the time of production.4.Conclusion and root cause the root cause of the problem is most probably patient or usage related.5.Rationale according to the quality standard and dhr files a material defect and production error can be excluded.An infection cannot result due to implant components.An infection is caused by microorganisms.There are several ways the infection due to microorganisms could have been triggered: · handling during surgery · underwent irrigation and debridement of the knee · missed dialysis furthermore due to the archived wound care hyperbaric report in sap, the patient had missed 1 week of dialysis because of a recent move and was unable to obtain transportation.As a result, he subsequently underwent an aspiration of his knee.Unfortunately, within 1-2 week' time, he started to develop a hot, red knee.We believe that his failed dialysis resulted in seeding of his knee.The patient subsequently was transferred to a nursing facility.Apparently a lack of attention was unfortunately instituted.The patient was not seen for 2 week in the postoperative setting, and upon his arrival to the office, grossly compromised dressing was identified with gross sloughing of the skin and necrosis.And additionally due to the statement of the head of biomechanical test laboratory "the implant shows no abnormalities", we exclude the implant components as the root cause for the patient infection.It appears that the wrinkling bone cement could be caused by too late use of the bone cement.The as tibia offset stem nz496z with adhesive bone cement was caused due to an improper handling because this should be implanted cementless.The visible damage of the tibia component nb013z could have caused due to explantation.A body reaction of the patient could led to no bone accrual.The groove of the femoral component could have caused due to bone splinters or cement residues.The visible damage of the hinge ring and femoral component could have caused due to hyperextension.It appears that the discoloration caused due to an oxidation effect which happens with all as coated implants if they are exposed to oxygen.It is an optical effect only and has no effect to the quality coating.
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