Model Number 1217-32-054 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Weakness (2145); Hypoesthesia (2352); No Code Available (3191)
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Event Date 04/22/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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 femoral nerve palsy postoperative: foot drop event is not serious and is considered mild there is a remote possibility that the event is related to device and is probably related to procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2020, (right hip).
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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, b7, h6 patient codes.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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Event Description
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Additional information received for medical records.Patient received a right depuy tha to treat end-stage arthrosis.The hip was placed with an anterior surgical approach.Two dome screws were used to secure the cup.After implantation, fluoroscopy showed a well-placed stem in neutral alignment and the cup in excellent position.The procedure was completed without complications.Clinic note dated 22 apr 202.Patient presented 6 weeks s/p tha with a partial femoral nerve palsy with foot drop.The surgeon notes that the patient has difficulty initiating his hip flexors, has noted quadriceps weakness, and femoral numbness.The surgeon notes that the patient has a history of lumbar stenosis and neuropathy, but believes this palsy is related to the anterior approach used to implant the tha.The patient reports one minor fall, with no pain or discomfort.No treatment is prescribed.Clinic note dated 24 jun 2020.Patient presents 3 months s/p right tha.Physical exam shows some return of felling and function.The patent is still unable to do a straight leg raise.The physician refers the patient for a nerve conduction study and an mri.No treatment is prescribed, and the patient will follow-up in 3 months.
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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.The provided x-ray images could not confirm the reported allegations.The root cause could not be confirmed.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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