STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 2101-0200 |
Device Problems
Device Operates Differently Than Expected (2913); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the product history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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Primary procedure, right hip.It was reported that the cup inserter would not attach to the cup.Upon inspection, the threads were observed to be malformed.Another inserter was immediately available and was used instead, no surgical delay was caused.
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Manufacturer Narrative
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An event regarding thread damage (¿the cup inserter would not attach to the cup¿) involving a cutting edge impactor was reported.The event was confirmed by visual inspection and mar analysis.Conclusions the reported event of ¿the cup inserter would not attach to the cup.Upon inspection the threads were observed to be malformed.¿ the event was confirmed based on a visual inspection which noted that the top thread was bent and a material analysis engineer noted, ¿in-service use damage observed on the device.Plastic deformation observed on the threads of the device, likely due to contact against a hard object.¿.
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Event Description
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Primary procedure, right hip.It was reported that the cup inserter would not attach to the cup.Upon inspection, the threads were observed to be malformed.Another inserter was immediately available and was used instead, no surgical delay was caused.
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Search Alerts/Recalls
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