Catalog Number UNK HIP FEMORAL AUGMENT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Syncope (1610); Fatigue (1849); Foreign Body Reaction (1868); Nausea (1970); Pain (1994); Weakness (2145); Discomfort (2330); Depression (2361); Test Result (2695); No Code Available (3191)
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Event Date 05/22/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number. the correction/ removal reporting number listed applies to the corresponding product code sold domestically.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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Asr claim letter and medical records received.Claim letter alleges pain, dizziness, nausea, weakness, fainting, fatigue, discomfort, depression, post-traumatic stress disorder, prostatic adenocarcinoma these signs and symptoms and diagnosis were due to metal poisoning, heavy metals cobalt and chromium in the body.Lab reports above 7 ppb.Claimant is seeking for damages.After review of medical records the patient was revised due to mechanical complication of internal joint prosthesis resulting to metallosis, elevated metal ions, vertigo and limping.Doi: (b)(6) 2008.Dor: (b)(6) 2017; left 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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.H10 additional narrative: product complaint # (b)(4).Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa- 001226.Ongoing post market surveillance is conducted per our procedures for this product.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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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 was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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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Search Alerts/Recalls
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