Catalog Number UNK HIP FEMORAL AUGMENT |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Foreign Body Reaction (1868); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Weakness (2145); Hypoesthesia (2352); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 01/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No 510# 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.
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Event Description
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Translated asr claim letter received.Claim letter alleges long series of luxations, high levels of chromium and cobalt and metallosis.It was also indicated that the plaintiff had pronounced sensory and motor deficit in the operated limb.It was reported that the patient had to undergo a number of revision operations to replace the prosthetic implant and promptly asking for compensation for all the damages suffered.Doi: (b)(6) 2005; dor: (not reported); left hip (asr).
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Manufacturer Narrative
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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 (b)(4).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.Patient code: no code available ((b)(4)) used to capture the blood heavy metal.
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Event Description
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Claim letter alleges iatrogenic injury, lesions to lumbar/trocular plexus and arthrosis of the left hip caused significant loss of sensitivity resulting to lack of motor capability, damage left femoral nerve, neurological damages, weak muscle tone , walking difficulty, reduce mobility, toxicity of implant device, dislocation, elevated metal ions and worsening pain.Claimant is seeking compensation for all damages suffered.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 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 : null.Device history batch : null.Device history review : null.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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