ARTHREX, INC.; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Device Problem
Failure to Align (2522)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/19/2022 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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On 12/19/2022, the michigan arthroplasty registry collaborative quality initiative (marcqi) provided a draft copy of their 2022 report indicating that 1 revision surgery had occurred to remove ibalance tka products due to malalignment.Further information was requested from marcqi but was not provided.
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Search Alerts/Recalls
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