Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Cyst(s) (1800); Hypersensitivity/Allergic reaction (1907); Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)
|
Event Date 01/30/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(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.
|
|
Event Description
|
The patient was revised to address metal-on-metal hip reaction.The stem was noted to be well-fixed.Two cysts were found.There were no other complications.Doi: (b)(6) 2007; dor: (b)(6) 2019 (right hip).
|
|
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.If information is obtained that was not available for the initial 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.H10 additional 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: 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, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # : (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H6 patient code: no code available (3191) used to capture the patient code device revision or replacement and blood heavy metal increased.
|
|
Event Description
|
Asr litigation records received alleging that the asr cup eventually produced metallic debris, loosened from the plaintiff's acetabulum, caused pain, produced abnormal blood metal ion concentrations, inhibited plaintiff's ability to walk and required revision surgery.The record further alleges pain, injury, compromised ability to walk, acetabular cup detachment, disconnection, creation of metallic debris, and/or loosening, pain and inhibition of the ability to walk.
|
|
Search Alerts/Recalls
|
|