Catalog Number 136552000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Date 08/06/2018 |
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.Occupation is a non-healthcare professional.(b)(4).
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Event Description
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Litigation alleges pain, discomfort, walking difficulty, elevated metal ions, injury, loss of mobility, loss of range of motion and disfigurement.Doi: (b)(6) 2008; dor: (b)(6) 2018; right hip.
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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.Additional narrative: 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.Device history lot : null.Device history batch : null.Device history review : null.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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Event Description
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After review of medical records, the patient was revised for painful metal-metal right hip replacement.It was indicated that the patient hip became painful and heavy.Patient also develop a limp as she has fallen several times and she was found to have an elevated serum chromium and cobalt.Operative notes reported that evaluation of the remaining bone stalk of the acetabulum revealed severe osteolysis.
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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. no code available (3191) is used to capture (medical device removal).
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Search Alerts/Recalls
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