Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Ossification (1428)
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Event Date 04/22/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis, as the device remains implanted; 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: 0002648920 -2021 -00402, 0002648920 -2021 -00403.
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Event Description
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It was reported the patient underwent initial left partial hip arthroplasty.Subsequently the patient was revised to total arthroplasty approximately 3 years later due to pain and arthritic disease progression.During the revision, significant ho was encountered and removed from the posterior capsule.The head was exchanged without complication.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 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.The following sections were updated: medical records provided confirmed the patient underwent a hip revision to address arthritic disease progression and pain and heterotopic ossification was identified.The device history records were reviewed and no discrepancies were identified.Following review of medical records, it was determined that no failure was detected with the implanted devices.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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