STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 2101-0200 |
Device Problems
Loss of or Failure to Bond (1068); Mechanical Problem (1384)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 09/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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It was reported that upon routine inspection of hospital inventory, the junction of the metal rod and the handle of the cup inserter was loose.No associated procedure.
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Manufacturer Narrative
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An event regarding damage involving cutting edge impactor was reported.The reported event was confirmed.Conclusion: the device was discovered during inspection.The reported device was returned for evaluation.A material analysis has been performed.The report concluded: examination of the returned device with engineer indicated that the device is severely worn due to in service use.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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It was reported that upon routine inspection of hospital inventory, the junction of the metal rod and the handle of the cup inserter was loose.No associated procedure.
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Search Alerts/Recalls
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