Catalog Number UNK HIP FEMORAL HEAD METAL ASR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Renal Failure (2041); Convulsion/Seizure (4406)
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Event Date 01/01/2020 |
Event Type
Injury
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Event Description
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It was reported as a potential ae regarding a hip replacement that was posted to the @jnjnews page under vendor tracking number: #880952 - text: hi @jnjcares @jnjnews @jnjglobalhealth i'm (__) and i¿m (b)(6).I am posting this tweet to express my concern regarding my health which deteriorated due to the faulty hip replacement i had to undergo, due to the defective part #faultyhipreplacement #jnj ".Doi: (b)(6) 2005.
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Manufacturer Narrative
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Product complaint # (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.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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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: device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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Search Alerts/Recalls
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