Catalog Number UNK HIP ACETABULAR LINER |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Foreign Body Reaction (1868); Pain (1994); Test Result (2695); No Code Available (3191)
|
Event Date 08/12/2020 |
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
|
It was reported that the patient recently had replacement of hip prosthesis that was put in 2006 titanium against titanium and have a re do because of high level of chromium and cobalt.Doi: 2006, dor: unknown, affected side: unknown.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary = no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
|
|
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.
|
|
Event Description
|
Additional information received stated that in 2006, the patient had bilateral depuy titanium hips done at ucla.The patient started developing pain and had an elevated metal ion level of 10.9 ppb in apr 2019.The left hip was revised at duke in (b)(6) 2020.
|
|
Event Description
|
After review of medical records, patient was revised to address metallosis.Revision notes stated that there was some metal staining reaction in soft tissues.The head was noted to be a ceramic with metal liner.Head and liner were removed.There was a large area of stripe wear.
|
|
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.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a device history record (mre) review, was not possible because the required lot code was not provided.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
|
|
Search Alerts/Recalls
|