Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Pain (1994); Insufficient Information (4580)
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Event Date 12/09/2022 |
Event Type
Injury
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Event Description
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It was reported the patient underwent an initial right knee arthroplasty.Approximately 2 years post implantation, the patient was revised due to unknown reasons.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Report source: foreign - (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03632, 0001822565-2022-03633, 0001822565-2022-03635.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported the patient underwent an initial right knee arthroplasty.Approximately 2 years post implantation, the patient was revised due to pain.It was reported that no further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the explanted femur, tibia, and articular surface covered in bio-debris.No further evaluation can be made from the provided picture.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tka was performed on (b)(6)2020.A revision was performed on (b)(6) 2022 for pain, and all implants were extracted and replaced with persona revision.The op record was not provided for the revision.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: radiographically unremarkable appearance of right total knee arthroplasty.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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Search Alerts/Recalls
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