STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON CR TIBIAL INSERT TRIAL SIZE 7 13MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number I-K34960713 |
Device Problems
Difficult to Insert (1316); Difficult to Remove (1528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, 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 during a knee procedure, the insert trials were difficult to engage into the baseplate trial, and then were very difficult to release.Post-op, the insert trials were tested with several other baseplate trials and exhibited the same behavior.Surgery was completed successfully with no delay.The insert trials are available for return, and the rep reported no further information is available.
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Manufacturer Narrative
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An event regarding alleged "assembly issue" involving a specialty trial was reported.The event was not confirmed.Method & results: device evaluation and results: examination of the returned device with engineer indicated damage observed on the posterior aspect consistent with contact against hard object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.A functional inspection was performed with the returned device and mated with a tibial template from finished goods (car 6541-2-607, lot s15329304).The complaint device assembled onto the template as intended.There was resistance disassembling both devices but could be from the damage found on the posterior side of the complaint device.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the reported event was not confirmed.Examination of the returned device with engineer indicated damage observed on the posterior aspect consistent with contact against hard object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.A functional inspection was performed with the returned device and mated with a tibial template from finished goods (car 6541-2-607, lot s15329304).The complaint device assembled onto the template as intended.There was a resistance disassembling both devices but could be from the damage found on the posterior side of the complaint device.If additional information are received, this investigation will be reopened and re-evaluated.
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Event Description
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It was reported that during a knee procedure, the insert trials were difficult to engage into the baseplate trial, and then were very difficult to release.Post-op, the insert trials were tested with several other baseplate trials and exhibited the same behavior.Surgery was completed successfully with no delay.The insert trials are available for return, and the rep reported no further information is available.
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Search Alerts/Recalls
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