DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 18F-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
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Model Number 55-0526 |
Device Problems
Use of Device Problem (1670); Malposition of Device (2616)
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Patient Problems
Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 10/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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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It was reported that the patient had stiffness, and fullness in the left hip region as well as a small pseudotumor.The 40mm metal on metal liner and 40mm head along with the stem were removed and replaced with 36/60 neutral liner and a new stem and 36mm delta 11/13 srom head was implanted.The patient requested all removed implants to be returned to him.Doi: (b)(6) 2008; dor: (b)(6) 2019; left hip.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.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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Upon pic supplemental preparation, further review of note a-3831530 and consultation with reviewer of the note resulted in findings that "nausea" does not correspond to patient's experience but was noted in intra-operative findings associated with the stem where stated "there was a little bit of nausea in the back portion of the femoral neck" (b)(4).All subjective reports of patient experience indicate "nausea none" throughout the medical record.The code nausea refers to gastrointestinal condition that would be subjectively reported by patient not as an intra-operative finding.
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Manufacturer Narrative
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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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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