STRYKER ORTHOPAEDICS-MAHWAH EXETER X3 RIMFIT ID22 OD40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number 63092240 |
Device Problems
Detachment Of Device Component (1104); Insufficient Information (3190)
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Patient Problem
Injury (2348)
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Event Date 09/01/2015 |
Event Type
Injury
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Manufacturer Narrative
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Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device discarded.
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Event Description
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Early loosening of the exeter rimfit cup was reported.The hospital used the rimcutter, and has experienced loosening.The loosening occurred at approximately one year post surgery.
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Manufacturer Narrative
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An event regarding cup loosening involving an exeter rimfit cup was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no items were returned.Medical records received and evaluation: the medical review indicated that several factors relating to surgical technique of cementation have been discussed and together have caused a problem with optimal placement of the cemented rimfit cup.Too much cement was left behind the cup resulting in a cement mantle that became too thick and caused thermal necrosis of the opposing bone which after slow resorption caused the cup to become loose.Because cementation technique is the responsibility of the surgeon, root cause of failure is procedure-related.There is no evidence of patient-related or device-related factors.Device history review: not performed as no lot code information was provided.Complaint history review: not performed as no lot code information was provided.Conclusions: the medical review indicated that several factors relating to surgical technique of cementation have caused a problem with optimal placement of the cemented rimfit cup.A thick cement mantle behind the cup caused thermal necrosis of the opposing bone which after slow resorption caused the cup to become loose.There was no evidence of patient-related or device-related factors.No further investigation for this event is possible at this time.If devices and / or additional information become available, this investigation will be reopened.
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Event Description
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Update: it should read: (b)(6) hospital have used the exeter rimfit cup for 5 years, and have seen some early loosening of the cup.They approached me with this information, and have stopped using the exeter rimfit cup for the time being.
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