Model Number N/A |
Device Problems
Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 11/01/2020 |
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 was discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products and mdrs, concomitant medical products: 00596403017, articular surface with locking screw size cd 17 mm height, lot#: 63939062.Mdr: 0001822565-2021-00288.
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Event Description
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It was reported that the patient hadn't had any issue with her knee until taking a fall.Since the fall she had been experiencing instability and a 'clicking feeling' when she would walk.The pain was not severe enough for her to seek medical attention.She felt the pain and clicking were worsening so went to be seen by dr for evaluation.Upon reviewing x-rays, it was obvious that the poly locking screw was out of place and needed to be revised.
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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.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.Radiographs were provided and x-ray evaluation by third party healthcare professional confirms that the locking screw was displaced.Review of the available radiographs identified the following: knee alignment is maintained with no facture; the poly locking screw is displaced and extends into the knee joint; bone quality is osteopenic.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
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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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