DEPUY ORTHOPAEDICS, INC. 1818910 SROM STM ST,36+6L NK,11X16X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM
|
Back to Search Results |
|
Catalog Number 563517 |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Host-Tissue Reaction (1297); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189)
|
Event Date 03/20/2017 |
Event Type
Injury
|
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.
|
|
Event Description
|
Pinnacle litigation received.Litigation alleges friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium metal ions to be released in the blood resulting in injury, pain, discomfort, inflammation, emotional distress, loss of mobility, loss of range of motion, mental anguish, and disfigurement.Doi: (b)(6) 2006; dor: (b)(6) 2017; left hip.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
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.Udi: (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.
|
|
Event Description
|
Pf alleges pseudotumor and metallosis.Pfs alleges metal toxicity from elevated metal ions, tissue damage caused by metal debris, inflammation, pain, pseudotumor filled grayish pus and limited range of motion.After review of medical records, patient was revised to address adverse locate tissue reaction and pseudotumor.Revision notes stated that there was large amount of yellow fluid with fibrinous debris and metal staining.Clinic visits reported of leg length discrepancy.Lab results for metal ions were above 7ppb.
|
|
Manufacturer Narrative
|
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.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.Device history lot: 2147906.Device history review: (b)(4) were manufactured per specification and all raw materials met specification.Devint-1508 is associated with this lot; there is no correlation with the failure mode.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.
|
|
Search Alerts/Recalls
|
|
|