Catalog Number 999800748 |
Device Problems
Osseointegration Problem (3003); Migration (4003)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Inadequate Osseointegration (2646); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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(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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It was reported that the patient was attempting to bend forward while at work and notice a pop in her hip and has had pain ever since.She was tested for metal and iron levels at some point in time and these were negative.It was stated that they obtained x-rays and found that the acetabular component had spun out and that this is a depuy asr acetabular component.Patient was then revised for failed right hip replacement, acetabular component loosening, adverse metal-on-metal reaction.Operative notes reported that there was debris at the trunnion head interface consistent with metal on metal reaction.The loosed cup was removed with no bone loss.Doi: (b)(6) 2007.Dor: (b)(6) 2019; 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.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.A mre (device history record) review will not be performed.
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Search Alerts/Recalls
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