STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #5R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5517F502 |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
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Event Description
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When box was opened, the outer blister was broken.
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Event Description
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When box was opened, the outer blister was broken.
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Manufacturer Narrative
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An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed by visual inspection.Conclusion: based on the visual inspection of the returned product the investigation concluded that the packaging damage was most likely caused by incorrect/excessive handling prior to opening of the product whereby the unit carton may have been compressed and/or dropped from a height causing the damage to the carton.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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Search Alerts/Recalls
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