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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Osteolysis (2377)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: foreign: (b)(6).Inoue, kazuya, et al."humeral bone resorption after reverse shoulder arthroplasty using." jses international, vol.4, 2020, pp.138-43, doi:https://doi.Org/10.1016/j.Jses.2019.11.007.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable 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.Product not returned.
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Event Description
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A journal article was retrieved from jses international (2020) that reported a study from (b)(6) that looked at the prevalence and risk factors of humeral bone resorption.The purpose of the study was to investigate the prevalence of humeral bone resorption after reverse shoulder arthroplasty procedures and to evaluate the risk factors for bone resorption.The study reviewed 48 reverse total shoulder arthroplasty patients with an uncemented humeral stem.The trabecular metal reverse shoulder system was used in 22 shoulders (zimmer); comprehensive reverse shoulder system, 11 (biomet); smr system, 10 (lima); and delta extend reverse shoulder system, 5 (depuy).The indication for arthroplasty was intractable pain and functional disability due to cuff tear arthropathy in 39 shoulders, retear after cuff repair in 4, malunion after proximal humeral fractures in 2, primary osteoarthritis in 2, and conversion from humeral head replacement in 1.The study population had a mean age of 76.5 years at time of surgery (range 70-88 years).A mean length of follow-up was conducted for 18.5 months (range 12-31 months).The study reported bone resorption of grade 4 in one patient; which was a (b)(6)-year-old female who received an inlay-type implant for cuff tear arthropathy.The patient exhibited bone resorption in zones 1 at 11 months postop at observed at 2 years postop.
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Search Alerts/Recalls
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