Catalog Number 00434903603 |
Device Problems
Unstable (1667); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Unintended Movement (3026)
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Patient Problems
Pain (1994); Tissue Damage (2104); Joint Dislocation (2374)
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Event Date 05/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Procode: phx.Concomitant medical products: glenosphere 36 mm diameter, cat# 00434903611, lot# 62552658.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01998.
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Event Description
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It was reported that a patient underwent a right total shoulder arthroplasty.Subsequently, the patient was revised approximately 6 years later for pain and possible instability (subluxation not full dislocation).Poly liner was removed and 36 glenosphere was exchanged for 40 glenoshpere and thicker poly liner implanted.Removed poly liner showed some inferior/posterior wear.During the surgical procedure, the surgeon mentioned that there may be signs of notching of the scapular neck.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ap film of the right shoulder demonstrates a reverse total shoulder arthroplasty in place.There does appear to be notching of the inferior scapular neck.Normal position of the glenosphere.Humeral component is intact with no radiolucency.No acute fracture.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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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