Model Number 115395 |
Device Problems
Fracture (1260); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Failure of Implant (1924)
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Event Date 08/12/2022 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent an initial shoulder arthroplasty.Subsequently, the patient underwent a revision surgery due to the central screw fracturing.The surgeon used only two screws, one screw inferior and one screw superior to implant the implant.The patient reportedly rolled over while asleep causing the fracture of the screw.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item#: unknown, unknown 15mm locking screws; lot#: unknown, item#:unknown, unknown medium augment comprehensive baseplate; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the provided picture identified that the central screw was fractured, and the baseplate was covered in biological debris.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: single view left shoulder demonstrated a reverse total shoulder arthroplasty with fractured central peg and loosening of the glenosphere.The humeral component was intact with no bony fracture.The overall fit appeared to be appropriate.Osteopenia was present.The root cause of the reported issue is attributed to the user rolling onto the implant in her sleep.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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