Model Number N/A |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530); Insufficient Information (4580)
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Event Date 01/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis location unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02313.0001825034 - 2021 - 02312.
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Event Description
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It was reported a initial right total hip arthroplasty performed.Legal notification received of unknown complications and indicate a possible revision has occurred approximately six (6) years post-implantation.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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An investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.
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Event Description
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It was reported the initial right total hip arthroplasty performed.Legal notification received patient developed right hip pain, and underwent testing with concern for septic hip and elevated metal ions.Patient underwent revision 16 years post implantation of head/liner, along with i&d performed.Surgeon note capsule had frank pus and metal debris, along with corrosion.Cultures performed revealed mssa and was treated with iv antibiotics.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. no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues metallosis, pain, infection, corrosion, elevated ion levels, and wear debris.No complications were noted during the revision.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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