Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Calcium Deposits/Calcification (1758); Fatigue (1849); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Discomfort (2330); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191); Swelling/ Edema (4577)
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Event Date 03/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Occupation: lawyer.(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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Der states that broken 10.5 small aml.Removed stem and metal on metal product.After review of the medical records clinical visit reported muscle spasm discomfort, weakness, swelling due to fall and heterotopic ossification.Doi: (b)(6) 2005; dor: (b)(6) 2018: right hip.
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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.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: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.
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Search Alerts/Recalls
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