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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Loss of Range of Motion (2032); Post Operative Wound Infection (2446)
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Event Type
Injury
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Manufacturer Narrative
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Brand name, common device name, manufacture name, city, and state, lot #, pma/510k: this report is for an unknown plates: lcp distal humerus plate/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device availble for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr and manufacture date: 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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Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: rollo, g.Et al (2021), open reduction and internal fixation using double plating with biological and artificial bone grafting of aseptic non-unions of the distal humerus: clinical results, strategies trauma limb reconstruction, vol.16 (3), pages 144¿151 (netherlands).The aim of this retrospective case series is to report the authors' prospective medium-term outcomes of the treatment of intra-articular, distal humeral aseptic non-union using orif with allograft bone grafting.A total of 16 patients (mean age of 44 years [range, 18-84 years]) were included in the study.After renewed reduction, fixation was performed using two plates (lcp®, depuy synthes¿, oberdorf, switzerland).Six patients received orthogonally placed plates and 10 patients parallel plates because of their fracture pattern.The mean follow-up period was 43 months (range, 24-62 months).The following complications were reported as follows: an 18-year-old male patient underwent an open arthrolysis 9 months after union because of capsular contractions.A 39-year-old male patient had skin infection/superficial wound infection successfully treated with antibiotics.A 45-year-old male patient underwent an open arthrolysis 4 months after union because of capsular contractions.A 42-year-old female patient underwent an open arthrolysis 5 months after union because of capsular contractions.A 39-year-old male patient had skin infection/superficial wound infection successfully treated with antibiotics; underwent an open arthrolysis 4 months after union because of capsular contractions.A 29-year-old male patient underwent an open arthrolysis 6 months after union because of capsular contractions.A 52-year-old male patient underwent an open arthrolysis 6 months after union because of capsular contractions.An 84-year-old male patient had skin infection/superficial wound infection successfully treated with antibiotics.This patient had neurological deficit existed pre-operatively which did not improve.This patient was the only one not to return to their preoperative functional level.A 36-year-old male patient underwent an open arthrolysis 3 months after union because of capsular contractions.A 58-year-old female patient underwent an open arthrolysis 5 months after union because of capsular contractions.A 56-year-old male patient had skin infection/superficial wound infection successfully treated with antibiotics; underwent an open arthrolysis 6 months after union because of capsular contractions.This report is for an unknown synthes lcp distal humerus plate/screws.This is report 10 of 18 for (b)(4).
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Search Alerts/Recalls
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