STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A PS BEADED #6R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5516F602 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/06/2018 |
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 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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It was reported that surgeon was performing a primary knee surgery and upon opening the implant, the inner box/blister was broken and surgeon thought sterility may be compromised as a result and opted not to use this device but another was on hand and readily available so surgeon used another device of same size/cat and completed the surgery without any delay.
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Manufacturer Narrative
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An event regarding pack damage involving a triathlon femoral component was reported.The event was confirmed by visual inspection of the returned product.One unit carton without its shrink wrap was returned for evaluation.Compression and indentation lines are visible on the opening end, corners and on the underside of the unit carton.The outer blister was returned with the tyvek lid attached on two sides.A patient label sticker is attached to the tyvek lid.For the purpose of this investigation the tyvek lid was removed from the outer blister.One side flange of the outer blister is broken away and remains attached to the tyvek lid.One side flange is also cracked but remains attached to the outer blister.There is evidence of a good seal on the remaining sides of the outer blister.The inner blister was returned unopened inside the outer blister.For the purpose of this investigation the tyvek lid was removed from the inner blister.There is evidence of a good seal between the tyvek lid and the inner blister.The returned device appears unremarkable.No medical records were received for review with a clinical consultant.Indicated all devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.Review of the returned product indicated: one unit carton without its shrink wrap was returned for evaluation.Compression and indentation lines are visible on the opening end, corners and on the underside of the unit carton.The outer blister was returned with the tyvek lid attached on two sides.A patient label sticker is attached to the tyvek lid.For the purpose of this investigation the tyvek lid was removed from the outer blister.One side flange of the outer blister is broken away and remains attached to the tyvek lid.One side flange is also cracked but remains attached to the outer blister.There is evidence of a good seal on the remaining sides of the outer blister.The inner blister was returned unopened inside the outer blister.For the purpose of this investigation the tyvek lid was removed from the inner blister.There is evidence of a good seal between the tyvek lid and the inner blister.The returned device appears unremarkable.This damage is consistent with inappropriate/excessive handling.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 surgeon was performing a primary knee surgery and upon opening the implant, the inner box/blister was broken and surgeon thought sterility may be compromised as a result and opted not to use this device but another was on hand and readily available so surgeon used another device of same size/cat and completed the surgery without any delay.
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Search Alerts/Recalls
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