STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ABGII MODULAR STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
|
Back to Search Results |
|
Catalog Number UNK_SHC |
Device Problems
Corroded (1131); Device-Device Incompatibility (2919)
|
Patient Problems
Injury (2348); Insufficient Information (4580)
|
Event Date 08/11/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported corrosion is considered to be under the scope of this recall.No further investigation is required.Device not returned.
|
|
Event Description
|
Abg 2 modular revision of left hip.Update spoke to rep.Intra-operatively, corrosion was noted at the stem/ neck interface.The trunnion had no wear, damage, or corrosion with the junction of the ceramic head.The stem construct, head, and poly liner were revised.Rep confirmed there are no allegations against the revised head and liner, and that no further information will be released by the hospital or surgeon.
|
|
Event Description
|
Abg 2 modular revision of left hip.Update spoke to rep.Intra-operatively, corrosion was noted at the stem/ neck interface.The trunnion had no wear, damage, or corrosion with the junction of the ceramic head.The stem construct, head, and poly liner were revised.Rep confirmed there are no allegations against the revised head and liner, and that no further information will be released by the hospital or surgeon.
|
|
Manufacturer Narrative
|
Reported event: an event regarding corrosion involving a abgii modular device was reported.The event was confirmed.Method & results: -device evaluation and results: device evaluation was not performed as no devices were received.-device history review: not performed as no lot was provided.-complaint history review: similar events have occurred for the catalog number and product family.These events were determined to be associated with ra 2012-067.Conclusions voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported corrosion is considered to be under the scope of this recall.No further investigation is required.
|
|
Search Alerts/Recalls
|
|
|