STRYKER ORTHOPAEDICS-MAHWAH SIZE 1 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
|
Back to Search Results |
|
Catalog Number 6721-0127 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Foreign Body Reaction (1868); Discomfort (2330)
|
Event Date 06/21/2023 |
Event Type
Injury
|
Event Description
|
Patient had a left hip revision due to post operative discomfort.Investigative revision performed to determine infection, no active infection during this process, determined reason for revision was metallosis.
|
|
Manufacturer Narrative
|
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.H3 other text : device not returned to the manufacturer.
|
|
Search Alerts/Recalls
|
|
|