Device Problem
Insufficient Information (3190)
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Patient Problems
Ossification (1428); Loss of Range of Motion (2032); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Roskidaylo et al."total elbow replacement coonrad-morrey in patients with rheumatoid arthritis." orthopaedic, fsbi research institute of rheumatology.72:a892.3-a892.No device or photos were received; therefore the condition of the device is unknown.Device history records cannot be reviewed since the lot number is unknown.This device is used for treatment.Product history search cannot be completed since the lot number is unknown.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definite root cause cannot be determined with the information provided.Initial reporter - the article was written by a roskidaylo, a logunov, s makarov and v amirdjanova.
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Event Description
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It is reported in a journal article that two patients experienced elbow stiffness following elbow arthroplasty.No further information is available.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This information does not change the root cause of the investigation previously provided.
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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.Date implanted - x-rays taken post-operatively indicate that the patient was implanted on or prior to (b)(6) 2012.
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Event Description
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It is reported in a journal article that one patient experienced elbow stiffness following elbow arthroplasty.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Provided radiographs were evaluated, and the reported event was not confirmed.X-ray reviewer stated, "elbow x-rays all show presence of coonrad/morrey semiconstrained total elbow arthroplasty components and posterior skin staples.On one set of lateral elbow x-rays (date unknown), bone graft is visualized between the anterior flange of the humeral component and the humeral cortex.The flange and bone graft are meant to resist torsional and posteriorly directed forces.No radiographic finding is present indicating an obvious cause for "elbow stiffness." neither device history record (dhr) review or complaint history review was able to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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