Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problems
Pain (1994); Weakness (2145); Shaking/Tremors (2515)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr¿s were submitted for this event.Please see reports: 0001822565 - 2017 - 06761, 0001822565 - 2017 - 06762, 0001822565 - 2017 - 06763.Concomitant medical products: 00430008700 glenoid component-pegged 52 mm lot# 62459668 00430205218 offset modular humeral head 18 mm lot# 62480079 00434811613 humeral stem 48 degrees 16 mm lot# 62445793.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.
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Event Description
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It was reported the patient is experiencing weakness and shaking while in extension.It was stated the subscapularis is deficient and it may have snapped back, not holding everything in place.The humeral bone has now migrated up.It has not been indicated the patient has been revised.No further information has been made available.
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Manufacturer Narrative
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This follow up report is being submitted to report additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of complaint history determined that no further action is required as no trends were identified.Root cause was unable to 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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