Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported patient has been indicated for revision due to unknown reason; however, no revision has been reported to date.Sales rep stated possibly poly wear but cannot confirm.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a3; g3; h2; h3; h6 a3 correction: unknown radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: bilateral total hip arthroplasties demonstrate slight superolateral eccentric positioning of the femoral heads with respect to the epicenter of the acetabular cups.This finding is more evident in the left hip and only slightly present in the right hip.There are secondary findings which would suggest polyethylene wear.No loosening or other contributing factors are noted.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.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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Event Description
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No additional information on the reported event.
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Search Alerts/Recalls
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