Model Number N/A |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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A review of the implant's manufacturing record indicates that it was manufactured to specification.Based on the information available, the root cause of the event cannot be determined.Should additional information be obtained to further this investigation, this report shall be updated.
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Event Description
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The patient contacted zimmer biomet inquiring if their knee implants were recalled.The patient is experiencing radiating bilateral knee pain and has described it as "pain on the bottom of both their knees and the pain runs up both thighs." the patient received two tm monoblock tibia components on (b)(6) 2012 (one in each knee); however, it is unknown which knee was implanted with the specific lot of tm monoblock tibia.As of this notification, the patient has not been revised as yet.
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Manufacturer Narrative
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Patient is status post bilateral knee tka.It is unknown which specific femoral component is mated with which tm monoblock tibia.However both tm monoblock tibias were manufactured, inspected and packaged within established process specifications and each is compatible with either femoral component that was implanted.Insufficient information was available for this investigation which precludes a detailed engineering assessment; therefore, this investigation is considered closed at this time.Should additional information become available, this investigation can be re-opened.
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Event Description
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Pain - no revision.
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Search Alerts/Recalls
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