Catalog Number 00840004415 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994); Limited Mobility Of The Implanted Joint (2671)
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Event Date 07/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical product(s): humeral screw kit 2 humeral screws cat# 00840009000 lot# 63364033; ulnar component size 4 cat# 00840002407 lot# 64083002; articulation kit size 4 cat# 00840009400 lot# 63991814.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00273, 0001822565 - 2020 - 00274, 0001822565 - 2020 - 00275.
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Event Description
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It was reported a patient underwent a right total elbow arthroplasty, ulnar decompression and anterior subcutaneous transposition, radial head excision.It was also reported the patient fell approximately 2 weeks later.No abnormal x-ray findings were noted at this visit.The patient had ongoing stiffness and slow progress with range of motion.Approximately 7 months after arthroplasty, a stress reaction in the medial column with minimal displacement was noted on x-ray.The patient was reportedly asymptomatic and implants were in correct placement.No revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no intraoperative complications noted during initial procedure one week post- operative visit notes the patient had a fall.X-rays do not show sign of fracture and components are well positioned.Patient is doing well 3 months post-operatively however rom is progressing slowly as patient is reluctant to work on it.Patient returns for 1 year follow up visit.Stiffness ongoing.Patient has tried rehab for stretching, but this was not effective against the scar tissue.Rom 30-110 degrees.X-ray continues to show medial condyle stress fracture that was seen on previous x-rays.Discussed scar tissue release but not planned.Review of the device history record(s) identified no deviations or anomalies during manufacturing of the humeral stem related to the reported event.A definitive root cause cannot be determined.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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