Catalog Number 211231 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Inadequate Osseointegration (2646); No Information (3190)
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Event Date 12/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: compr srs prox bdy - lg 62mm cat# 211220 lot# 747200.Versa-dial 38x19x39 hum head cat# 113022 lot# 692250.Versa-dial/comp ti std taper cat# 118001 lot# 319860.Compr srs ic seg - 60mm cat# 211225 lot# 684190.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.
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Event Description
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It was reported that patient underwent total shoulder arthroplasty.Subsequently, the patient requires a revision due to loosening and limb length discrepancy, but revision has yet to occur.The surgeon has requested a humeral expandable to reconstruct the humeral bone.Patient is still growing, and the surgeon believes an expandable device would help limit the total number of surgeries required for the patient.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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It was reported that the patient underwent a revision approximately 13 months after initial procedure.The custom device that was specially developed could not be used due to an abnormality with the patient's autograft.Instead, the surgeon decided to use a static srs humeral component to finish the procedure.Attempts have been made and no additional information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b3, b4, b5, d7, g4, g7, h2, h10.
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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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Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: very limited imaging is provided.Osseous gap within the humerus along the right shoulder arthroplasty humeral stem and lucency along the stem suggesting loosening.Additional information does not change the root cause of the previous investigation.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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