Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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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 a revision, however, a revision has not been reported.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.Reported event was unable to be confirmed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: image 1 demonstrates anatomic alignment of the right hip arthroplasty without abnormality.Image 2 demonstrates dislocation of the right hip arthroplasty.There is suspected osteolysis at the greater trochanter in gruen zone 1 and possibly at the inferomedial margin of the acetabular cup.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 further event information available at the time of this report.
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Search Alerts/Recalls
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