Catalog Number 999890245 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Osteolysis (2377); Thrombosis/Thrombus (4440); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
|
Event Date 04/12/2022 |
Event Type
Injury
|
Event Description
|
Revision completed due to infection.Surgeon removed asr.No metal issue reported.Aml stem was left in.Doi: 2009, dor: (b)(6) 2022, affected side: unknown.
|
|
Manufacturer Narrative
|
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
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.E3 initial reporter occupation: lawyer.
|
|
Event Description
|
Patient alleges severe pain, discomfort, elevated metal ion, injuries, emotional distress, disability, disfigurement, economic damages, medical and hospital expenses.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
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: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Event Description
|
Plaintiff preliminary disclosure and medical records received.After review of the medical record, the patient was revised due to pseudotumor.Inflammatory markers were elevated.The patient had deep vein thrombosis.Revision notes stated that there was bursitis, scar tissue was released, there was gray staining of the pericapsular tissue consistent with metallosis.Osteolysis was present along the calcar region of the femur.The cup was removed with minimal bone loss.Added medical history and product details.
|
|
Manufacturer Narrative
|
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Search Alerts/Recalls
|