ZIMMER GMBH ZNN, CMN LAG SCREW, 10.5 MM, 90 MM, INCLUDING SET SCREW; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Death (1802)
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Event Date 06/03/2017 |
Event Type
Death
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Manufacturer Narrative
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An e-mail requesting the following additional information was sent on june 9, 2017 to the appropriate representatives: the reason why the patient needed a treatment? what was the diagnosis for the implantation of a znn nailing system? the date of the implantation of the znn nailing system? when exactly was the infection detected? how was the infection detected? which measures/actions were taken right after the infection was detected? what exactly happened to the patient as this bacterial infection occurred? after how many hours/days the patient death occurred as the infection was detected? are there already any lab results regarding the infection available? patient gender (male/female)? patient dob (date of birth), weight, height, bmi? patient relevant history (illness, previous surgery, patient anatomy)? surgical report of the implantation of the znn nailing system? will the implants remain in patient¿s body? any available pictures or x-rays? an immediate preliminary investigation of the manufacturer showed: -the sterilization certificates of the devices have been reviewed and no deviations and/or abnormalities has been found.-the device history record were reviewed and found to be conforming.-complaint history review: for the actual complained zimmer (b)(4) design products (cmn femoral nail, ccd 130°, right, 10 mm, 32 cm lot 2895429, ref 47-2493-322-10 & znn, cmn lag screw, 10.5 mm, 90 mm, including set screw lot 2866006, ref 47-2485-090-10) no complaints has been reported in regards to death and/or infection.Furthermore, a complaint history review on the full product scope of znn nails and lag screws has been performed.One complaint regarding death has been found ((b)(4); the event of this complaint has been occurred in the year 2012 in (b)(6) and a (b)(4) authority and a mdr to fda was filed).The investigation showed no correlation with the product.- a first review from the health care professional with the already existing information does not show a correlation with the products.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).
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Event Description
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It is reported by a hospital, that a patient died due to clostridium perfringes infection after he was implanted with a cmn femoral nail, ccd 130°, right, 10 mm, 32 cm.The date of implantation, as well as the date of occurrence (date of death), is unknown at the time being.Note: this is a split case, devices manufactured by zimmer inc.Will be reported in (b)(4).
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Manufacturer Narrative
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Additional information was received on june 13, 2016.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).
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Manufacturer Narrative
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The device manufacturing quality records indicate that the released components met all requirements to perform as intended.No trend identified.Event summary: initial event description: it was reported that unfortunately after using the znn nailing system a patient death was occurred.The patient had a clostridium perfringes infection.Detailed event description: it was reported that the patient falls down in her house and 2 hours later she was brought to the hospital.She is taken to the surgery on the same day ((b)(6) 2017).During the surgery no problem observed.The infection is not noticed that day.On (b)(6) 2017 an infection (clostridium perfringes) was detected in the patient.Afterwards, the right leg of the patient was amputated.On (b)(6) 2017 patient has died.The implants remain in the body of the patient.No medical data such as x-rays, surgical notes or any other case-relevant documents received.No product was returned to zimmer biomet for in-depth analysis.The compatibility check was performed from surgical technique and showed that the product combination was approved by zimmer biomet.The internal documents were reviewed.The sterilization certificates have been reviewed and no deviations and/or abnormalities have been found.This means a safety margin of 10-6 can be confirmed.The dhr (device history records) indicate that the released components met all requirements to perform as intended.Therefore it can be concluded that the devices were according to product specification.For the actual complained products (ref 47-2493-322-10 / lot 2895429 and ref 47-2485-090-10 / lot 2866006) no complaints has been found in regards to death and/or infection.After complaint history review on the full scope of the znn nails and znn lag screws one complaint regarding death has been found (cpt120006077; the event of this complaint occurred in the year 2012 in (b)(6) and a mdv to the (b)(6) authority and a mdr to fda was filed).In cpt120006077 the nail was broken and revised.In the night after the surgery the patient death occurred (the patient had have cardiovasculaire antecedent).There was no material failure or a relation between the patient death and the zimmer products.No infection (clostridum perfringes) was noted.- this case (reported event with clostridium perfringens) was reviewed by a healthcare professional: postoperative infections on bones, soft parts or joints result from a local or systemic immune deficiency and a local transmission of germs.If the germ transmission is massive high and the infective defense is sufficiently disturbed, then the germ multiplication occurs.It is also known that an infection with clostridum perfringes are often leading to patient death if not treated (during hospitalization) immediately after detection.Postoperative infections are usually wound healing disorders that occur in connection with surgical procedures.Clostridium perfringens is often found in heavily polluted wounds.A corresponding constellation as a cause of the postoperative infection cannot be taken from the received documents.In the literature, clostridium perfringens can be identified as a cause of sepsis in the gynecological area.As the patient was a female, this can be also possible.Clostridium perfringens is often found as the responsible germ of a food poisoning.This can be probably excluded in the present case.Based on the given information no link between the incident in the hospital and our product could be drawn.Root cause analysis: root cause determination using rmw: - adverse body reaction due to micromotion between components leads to patient exposition to metallic particles => possible, it is unknown how the patient body did act after the implantation of the device.- patient exposed to biological contaminants due to implant design features lead to failure of sterilization process.Not possible.-> a systematic issue with design and/or material properties would have been detected as part of a trend review.- patient exposed to biological contaminants due to unsterile implant due to inadequate packaging or packaging failure.Not possible.-> a systematic issue with design and/or material properties would have been detected as part of a trend review.- adverse body reaction due to manufacturing residuals.Not possible.-> the device was according to product specification.- corrosion product enter wound and can cause adverse body reactions due to corrosion products release from implant.Not possible.-> the device was according to product specification.- non-biocompatible material enter wound and can cause adverse body reaction due to device and/or packaging material not biocompatible.Not possible.-> a systematic issue with design and/or material properties would have been detected as part of a trend review.- non-biocompatible material enter wound and can cause adverse body reaction due to device and/or packaging material contains additives.Not possible.-> a systematic issue with design and/or material properties would have been detected as part of a trend review.- non-biocompatible material enter wound and can cause adverse body reaction due to leakage of substances which are cytotoxic.Not possible.-> as no complications occurred during the surgery.- exposure to substances of very high concern can cause adverse body reaction due to leakage of substances of very high concern.Not possible.-> as no complications occurred during the surgery.- contaminated device will be used due to packaging is defective due to wrong transportation conditions.Not possible.-> the transportation condition is known and no issue was noted on that.- contaminated device will be used due to packaging is defective due to inadequate storage/handling conditions.=> possible, it can be possible that the device was defective due to inadequate storage/handling.- contaminated device will be used due to unintented unwrapping of device packaging => possible, it can be possible that the device was unwrapped.- patient exposed to biological contaminants due to explanted implant is used for new implantation surgery.=> possible, it is possible that the explanted implant is used for new implantation.- patient exposed to biological contaminants due to devices are processed not as indicated => possible, it is unknown how the device was processed in the hospital.Conclusion summary: on (b)(6) 2016 a surgeon from (b)(6) reported a patient death, occurred after zimmer biomet implants were used.The reported patient death is due to an infection with a clostridum perfringes bacterium.From literature it is also known that an infection with clostridum perfringes are often leading to patient death if not treated (during hospitalization) immediately after detection.The dhrs as well as the sterilization certificates show that the processing of the affected devices was according specification.The sterility certificates show a safety margin confirmed being of 10-6.The sterilization certificates have been reviewed and no deviations and/or abnormalities have been found.Therefore it can be concluded that the device was according to product specification.No link between the incident in the hospital and our product could be drawn.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).
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Event Description
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It is reported by a hospital, that a patient died due to clostridium perfringes infection after he was implanted with a znn, cmn lag screw, 10.5 mm, 90 mm, including set screw, on (b)(6) 2017.
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