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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arthritis (1723); Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Physical Asymmetry (4573)
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Event Type
Injury
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Event Description
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Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: zhuoqian z., (2021) comparison of monoaxial locking plate and polyaxial locking plate in the treatment of sanders type iv complex intra-articular calcaneal fractures, journal of mathematical medicine volume 34 issue 7, pages 1-2 (china) this study aims to compare the effect of uniaxial locking plate and polyaxial locking plate in the treatment of sanders type iv complex intra-articular calcaneal fractures.From february 2017 to june 2020, february 2017 to june 2020 general information of 54 patients with sanders type iv complex intra-articular calcaneal were divided into control group (n = 26) and observation group (n = 28).The control group consisted of 12 males and 14 females, aged 19 to 41 years, with an average age of (30.31 ± 4.73) years; and the observation group consisted of 15 males and 13 females, aged 20-43 years, with mean one of (31.25 ± 5.03) years; the causes of injury.The observation group was treated with polyaxial locking plate.The control group was treated with uniaxial locking plate, which was the same as the control group.The uniaxial locking plate in the control group was replaced with uniaxial locking plate (shanghai johnson & johnson medical device).Reported complications: (n=4) fair cases according to maryland score for foot function 5 months after surgery.Where postoperative pain is more obvious, there is slight claudication, score 50 ~ 69 points is fair.(n=2) poor cases according to maryland score for foot function 5 months after surgery.Where pain is very obvious, joint stiffness, scores < 50 points.(n=1) subtalar joint trauma arthritis (n=1) incision infection (n=2) loss of reduction (n=4) complication incidence -5 months after the operation, bohler angle, gissane angland root bone width levels of the observation group were significantly lower than those of the control group and root bone height level was significantly higher than that of the control group this report is for an unknown synthes uniaxial locking plate.This is report 2 of 2 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.
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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.Additional narrative: this report is for one (1) unk - screws: locking: calcaneal and lot numbers are unknown.Without the specific part number, the device history records review could not be completed; and the udi number is unknown.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(6) hospital.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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Search Alerts/Recalls
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