Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 12/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: item 42539905295 lot 64719765; item 42558000202 lot 64623165; item 42528200508 lot 64561694.Foreign (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 001822565-2021-00020.
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Event Description
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It was reported that unicompartmental knee arthroplasty was performed with ppk; subsequently about one week after the primary operation, the patient's tibia bone cracked from a pinhole made by new type cut guide.The patient bone has been observed.A revision is not planned so far.Attempts have been made and no further information has been provided.
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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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Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0001825034 - 2021 - 01403.
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Search Alerts/Recalls
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