Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Loss of Range of Motion (2032)
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Event Date 05/16/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Event Description
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It was reported following the patient's implant procedure on (b)(6) 2016, the patient lost feeling in his hips and legs.The patient went to the emergency room and was subsequently explanted the same day.The patient reported some sensation coming back in his legs on (b)(6) 2016, and as of (b)(6) 2016, the patient was reportedly doing better.
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Manufacturer Narrative
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Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Follow-up identified per the physician's office, the patient was doing better in terms of being able to move or feel his legs.
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Search Alerts/Recalls
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