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Model Number N/A |
Device Problems
Mechanical Problem (1384); Unstable (1667); Noise, Audible (3273)
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Patient Problems
Pain (1994); Weakness (2145); Limited Mobility Of The Implanted Joint (2671)
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Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects 14.Intraoperative or postoperative bone fracture and/or postoperative pain.Additionally, the patient is to be made aware in advance of surgery and warned of general surgical risks, possible adverse effects as listed, and to follow the instructions of the treating physician, including follow-up visits.(b)(4).This report is number 4 of 4 mdrs filed for the same event (reference 1825034-2016-04957 / 04960).
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Event Description
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Patient in clinical study reports pain, instability, and impingement approximately 6 weeks post implantation.Pain and instability approximately 3 months post implantation, and increased soreness, clicking, weakness and catching sensation approximately 7 months post implantation.There has been no reported revision to date.
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Manufacturer Narrative
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Issue is adverse event and product problem.Concomitant medical product: versa-dial 54x21x64 humeral head, catalog#: 113063, lot#: 838310; lg hybrid glenoid base 4 mm, catalog#: 113956, lot#: 076130; pt hybrid glenoid post regenerex, catalog#: pt-113950, lot#: 376080; comprehensive nano humeral pps 40 mm, catalog#: us-115740, lot#: 427500.Reported event was confirmed by review of provided x-rays.X-ray reviewer stated, "radiographic findings of anterior subluxation of the humeral head component on axillary view, predisposing to subscapularis impingement, is demonstrated.Radiographic findings of glenoid and humeral component loosening may also be associated with pain." device history record (dhr) was reviewed and no discrepancies were found.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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