Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 07/31/2022 |
Event Type
Injury
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Pma¿ 510k: this report is for an unk - ria/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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This report is being filed after the review of the following journal article: ahmed h.Elhessy., et al (2022)/fusion revision surgery with reamer-irrigator- aspirator to harvest autograft after spinal pseudarthrosis, cureus 14 (7), 1¿11 (usa).This retrospective study is a collaborative study between orthopedic surgery and neurosurgery departments to utilize femur intramedullary autograft harvested using the ria system.Between august 2014 and december 2017, 11 patients who underwent 12 spa revision using the ria system (depuy synthes, west chester, pa) were identified, with females(n=7) and males (n=4).Mean + - standard deviation (sd) of age was 53.7 years (range: 40-62 years).Regarding the levels of presentation, eight cases (66.7%) were lumbosacral, two (16.7%) were lumbar and two (16.7%) were cervical.The time of presentation from the last procedure was 19.9 months (range; 8-36 months).The following complications were reported as follows: 1 patient was infected and did not achieve successful fusion initially; he underwent several debridements to eradicate infection and ended with hardware removal.4 patients (36.4%) had postoperative knee pain.1 patient had a complex meniscal tear on postoperative mri.The last patient with postoperative pain had a tense knee effusion two days after the graft harvesting, which was managed by surgical evacuation of the hematoma.This report is for an unknown synthes reamer-irrigator-aspirator.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unk - ria.This is report 2 of 2 for complaint (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Initial reporter facility name and address: international center for limb lengthening, rubin institute for advanced orthopedics.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.E3: reporter is health care professional.
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Search Alerts/Recalls
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