STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 36MM/+10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Model Number 06-3610 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding incorrect selection involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned clinician review: no medical records were received for review with a clinical consultant.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: no further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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Brought pt to operating room to change fem.Head.Update 28/april/2021 (b)(4): spoke to rep.In revising the patient's hip due to a perceived limb length discrepancy, a 32+0 femoral head was revised to a 36 +10 femoral head.Post-operatively, discovery was made that the 36mm head had been implanted into a liner with inner diameter of 32mm.The patient was brought back to the operating room and the head and sleeve were exchanged for the appropriate size.
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