Catalog Number 999800748 |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Injury (2348); No Code Available (3191); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/06/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.
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Event Description
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Asr litigation records received.Litigation alleges debilitating pain, injury, discomfort, suffering and emotional damage.Doi: (b)(6) 2009; dor: none reported; left 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.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 patient code: no code available (3191) used to capture the limb asymmetry, bone injury and device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Pfs indicated the test for cobalt-chromium were below 7 ppb.After review of medical records, the patient was revised for bearing wear and secondary reaction.Operative note reported that patient leg length was increased and note to have a minimal bone loss.
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Manufacturer Narrative
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Product complaint (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a2 (age), b5, b6, b7 and h6 (clinical and device codes).H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the blood heavy metal increased.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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After review of medical records, it was indicated that the patient complained of pain, instability and clicking.Lab results for metal ions were provided and it was above 7, however the collection date of the latest result and values were noted provided.In addition, medical records reported that the patient undergone multiple revision.
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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: previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched 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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