Model Number N/A |
Device Problems
Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
No Information (3190)
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Event Date 04/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical product: partial femur cemented size 5 left medial, item# 42558000501, lot# unknown.Partial articular surface left medial size f 9 mm thickness, item# 42518200609, lot# unknown.Report source - (b)(6).Customer has not indicated whether or not the product will be returned to zimmer biomet for investigation.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 a patient was revised approximately one and a half years post implantation due to aseptic loosening of the tibia.There is no additional information available 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 is being submitted to relay additional information.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.D10- medical product palacos r +g 2x40 g item# unknown lot# unknown.
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Search Alerts/Recalls
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