STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5532-G-409 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Scar Tissue (2060); Synovitis (2094); Ambulation Difficulties (2544)
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Event Date 11/02/2014 |
Event Type
Injury
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
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Event Description
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Following her primary tka, her postoperative course was complicated by contracture requiring manipulation under anesthesia.Subsequently, she developed patellar clunk syndrome requiring arthroscopic debridement.Patient then presented to dr.(b)(6) clinic on (b)(6) 2014, complaining of chronic pain about the left knee with difficulty ambulating and at nighttime, pain at rest and with activities.Also complains of giving away and instability.Patient underwent revision tka on (b)(6) 2014 involving liner exchange, excision of plica and dense scar tissue, and synovectomy.
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Manufacturer Narrative
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An event regarding instability of a triathlon all-poly insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no devices were returned for evaluation.Medical records received and evaluation: consultation and review of the records with a consulting clinician concluded that there is no evidence that this event was due to factors of faulty primary knee component design, manufacturing or materials.Device history review: all devices accepted into final stock conformed to specification.Complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Review of the received records with a consulting clinician indicated that past medical history, primary operative report or listing of the implanted components, examination of the explanted insert, and follow-up subsequent to the (b)(6) 2014 revision surgery would be required to investigate this event any further.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device.
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Event Description
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Following her primary tka, her postoperative course was complicated by contracture requiring manipulation under anesthesia.Subsequently, she developed patellar clunk syndrome requiring arthroscopic debridement.Patient then presented to dr.(b)(6) clinic on (b)(6) 2014, complaining of chronic pain about the left knee with difficulty ambulating and at nighttime, pain at rest and with activities.Also complains of giving away and instability.Patient underwent revision tka on (b)(6) 2014 involving liner exchange, excision of plica and dense scar tissue, and synovectomy.
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