(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: us-115736, compr nano hmrl pps 36mm, lot 532100, 118001, versa-dial/comp ti std taper, lot 615790, 113952, sm hybrid glenoid base 4mm, lot 856280, pt-113950, pt hybrid glen post regenerex, lot 019720.Multiple mdr reports were filed for this event, please see associated report: 0001825034 - 2018 - 11219.
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It was reported that approximately 4 years post implantation, the patient had complaints of inadequate range of motion, and difficulty reaching behind the back.No medical intervention has been taken to date.Attempts have been made and no further information has been provided.
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs.Review of the x-rays demonstrated subluxation of the l shoulder arthroplasty components, as noted.Device history record (dhr) was reviewed and no discrepancies were found.A definite root cause cannot be determined with the information 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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