Model Number 1217-22-052 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nerve Damage (1979); Pain (1994); Physical Asymmetry (4573)
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Event Date 06/21/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Clinical adverse event received for post operative sciatic nerve pain.Event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2021.Date of event: (b)(6) 2022, (right hip).Treatment: exploration was performed and there was no evidence of tethering.The nerve was palpated and found to be free of any tension.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Through follow up it is now understood there is no allegation associated against a product malfunction.Based on the photographic evidence nothing indicative of a device nonconformance was found.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: d6a.
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Event Description
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Doi: (b)(6) 2022: patient received a right tha to treat end-stage osteoarthritis.The patient received an emphasys stem, pinnacle cup, cocr head, and altrex liner.The surgeon notes that, due to the patient¿s anatomy, the stem sat a little proud resulting a minimal lengthening of the right leg causing a slight leg length discrepancy.The procedure was completed without complications.Doe: (b)(6) 2022: after the spinal anesthesia wore off, the patient complained of sciatic pain.The patient was brought back to the or to determine if the sciatic nerve was tethered with one of the sutures.Upon entering the joint, the surgeon determined that the sciatic nerve was not tethered nor tight.No operative corrections were performed.The procedure was completed without complications.Clinic note dated : (b)(6) 2022: patients foot drop and sciatic nerve palsy are completely resolved.The patient does have limb asymmetry, with the right leg slightly longer than the left.The patient is prescribed a 9 mm shoe lift.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Added: b5 and h6 (clinical code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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