Catalog Number UNK HIP ACETABULAR CUP ASR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/02/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter 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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Legal and medical records received.After review of medical records, it was reported that the patient presents with incredible pain, weakness and limitation to physical activities.It was also noted that patient suffers from metal on metal reaction.Elevated metal ions.The patient was then revised for failed right total hip.Operative notes reported that there was a very small effusion.There was a small amount of corrosion on the trunnion.The stem was secure with an approximately 15 degrees of anteversion.X-ray reviewed which do show well fixed components, mri does show obvious effusion w/o psuedotumor.Doi: (b)(6) 2008, dor: (b)(6) 2021.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.An mre (device history record) review will not be performed even when lot code(s) are known.
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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.An mre (device history record) review will not be performed even when lot code(s) are known.
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Event Description
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Litigation alleges pain, discomfort, increase metal levels, permanent injuries, emotional distress, disability, disfigurement and economic damages including medical and hospital expenses for revision surgery followed by monitoring, rehabilitation and pharmaceutical costs.
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Event Description
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Pfs alleges metallosis, alval, joints disabilities, limited physical activity, joint stiffness and swelling.
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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 (b)(6) 2010, and the asr product codes are now considered inactive.An mre (device history record) review will not be performed even when lot code(s) are known.
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Search Alerts/Recalls
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