Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994)
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Event Date 01/07/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: event occurred in (b)(6).
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Event Description
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It was reported that approximately 1 month post implantation, the patient experienced pain and was found to have a tibial bone fracture.The patient has indicated a possible revision, but one has not been confirmed yet.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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Upon receipt of additional information, it has been determined that this device was reported under the incorrect manufacturing site mfr.The initial report was forwarded in error and should be voided.Please see 0001825034-2020-00490.
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Event Description
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Upon receipt of additional information, it has been determined that this device was reported under the incorrect manufacturing site mfr.The initial report was forwarded in error and should be voided.Please see 0001825034-2020-00490.
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Search Alerts/Recalls
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