ZIMMER BIOMET, INC. EXPLOR 12X22MM IMPLANT HEAD; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER/EXTREMITIES
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Catalog Number 11-210032 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/03/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03421, 0001825034-2021-03423.Medical product: item#: unknown, unknown explore locking screw; lot#: unknown.Item#: unknown, unknown explore stem; item#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, the product was requested but not returned by hospital.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 that the patient underwent a left elbow arthroplasty approximately eight (8) years ago for an unknown reason.Subsequently, the patient was revised due to the loosening and disassociation of implants.
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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.Lot identification is necessary for review of device history records; lot identification was not provided.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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