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Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 08/17/2020 |
Event Type
Injury
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Event Description
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It was reported a patient, with metastatic bone disease, had a left reverse total shoulder arthroplasty on approximately 3 years ago.Subsequently, about 6 months later, the patient underwent a revision of the stem due to dislocation.The patient was withdrawn from the study and no additional information has been provided.Attempts have been made and there is no further information at this time.
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Manufacturer Narrative
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(b)(4).D10 - medical product: catalog #: 211241, compr srs mod stem - 6x150mm, lot # 11771922; catalog #: 211216, compr srs prox bdy - sm 58mm, lot # 261100; catalog #: 211228, compr srs mod rgx aug - sm, lot # 209220; catalog #: 211225, compr srs ic seg - 60mm, lot # 936310 catalog #: unknown, cement, lot # unknown; catalog #: unknown, glenosphere, lot # unknown.H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 001825034-2023-02757 h3 other text : not returned.
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Manufacturer Narrative
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(b)(4).Updated: b4, b5, d2, g3, h1, h2, h6, h10 corrected: h6 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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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).Reported event was confirmed by radiograph review.Medical records/radiographs identified the following: implant fit is maintained.Initial alignment was anatomic but 6 month images demonstrate a dislocation of the reverse-type arthroplasty.Bone quality is osteopenic on all images.There is no evidence of loosening or other abnormality.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not 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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