STRYKER ORTHOPAEDICS-MAHWAH EXETER 2.5 I M PLUG 16MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number 09390116 |
Device Problems
Break (1069); Fracture (1260); Material Integrity Problem (2978)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 01/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into vendor stock with no reported discrepancies.There have been no other similar events for the lot referenced.
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Event Description
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The stryker sales representative reported that 2 cement restrictors broke during insertion.The first time the restrictor split, the surgeon had to manually remove each of the pieces.These were successfully removed from the patient.The second time, on advice from senior surgeon, he opted to leave the restrictor in.The top broke off this particular one but it was so well fixed it was proving difficult to remove.Two different introducers were used.These have been used without issue in previous surgeries.
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Manufacturer Narrative
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An event regarding a fractured device involving an exeter bone plug was reported.The event was confirmed by a photograph provided.Method & results: -device evaluation and results: a photograph provided shows a fractured plug immediately post-explantation.Conclusions: the exact cause of the event could not be determined with the available information.Return of the reported device for evaluation is required to complete the investigation for determining the root cause.No further investigation for this event is possible at this time as the device was not received by stryker.If additional information becomes available, this investigation will be reopened.
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Event Description
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The stryker sales representative reported that 2 cement restrictors broke during insertion.The first time the restrictor split, the surgeon had to manually remove each of the pieces.These were successfully removed from the patient.The second time, on advice from senior surgeon, he opted to leave the restrictor in.The top broke off this particular one but it was so well fixed it was proving difficult to remove.Two different introducers were used.These have been used without issue in previous surgeries.
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