STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Model Number 6020-3535 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Inflammation (1932); Injury (2348); Reaction (2414)
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Event Date 07/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
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Event Description
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Notified of failed trunion by surgeon on july 26 2020, revision surgery planned and executed on (b)(6) 2020, trunion on stem worn by metal head.Metallosis identified on entry into the capsule.
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Search Alerts/Recalls
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