DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 18B-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
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Catalog Number 521485 |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Injury (2348); Inadequate Osseointegration (2646)
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Event Date 12/06/2012 |
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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(b)(4).Litigation alleges that patient experienced hip pain, causing difficulty ambulating and sleeping.Additionally, it is alleged that implant is releasing metal ions into patient's body.Update dec 05, 2017: pfs and medical records received.In addition to what were previously alleged, pfs alleges device failure resulting to injuries.After the review of medical records for mdr reportability, it was stated that the patient was revised to address wear and femoral component loosening.Clinical notes reported of pain, discomfort, restricted active and passive range of motion, antalgic gait and radiographic criteria consistent with loosening of his hip.Laboratory result for cobalt was below 7ppb.Added stem and sleeve impacted products.Doi: (b)(6) 2007; dor: (b)(6) 2012; left hip.
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Manufacturer Narrative
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Udi: (b)(4).
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Event Description
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In addition to what were previously alleged, ppf alleges metal wear and metallosis.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision depuy synthesof 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.Additional narrative: product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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