STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5521-B-500 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Pain (1994); Injury (2348); Joint Dislocation (2374)
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Event Date 12/11/2017 |
Event Type
Injury
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Manufacturer Narrative
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An event regarding revision due to dislocation of a triathlon insert was reported.Clinician review of the event determined that the triathlon ts baseplate component was mal-positioned.The event was confirmed based on the clinician review of the medical records provided.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: clinician review of the medical records provided indicated "no examination of any explanted components except for the insert from the (b)(6) 2018 revision surgery and no primary left total knee arthroplasty operative report or list of components are available for review.The medial position of the revision tibial component and the distal position of the joint line in the revision total knee arthroplasty likely resulted in increased stress to the ts insert stability resulting in two dislocations and a later anterior implant subluxation.There is no evidence that factors of implant design, manufacturing or materials were responsible for this clinical situation".Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: complaint history review confirmed that there have been three other similar events for the reported lot.Conclusion: clinician review of the medical records provided indicated "no examination of any explanted components except for the insert from the (b)(6) 2018 revision surgery and no primary left total knee arthroplasty operative report or list of components are available for review.The medial position of the revision tibial component and the distal position of the joint line in the revision total knee arthroplasty likely resulted in increased stress to the ts insert stability resulting in two dislocations and a later anterior implant subluxation.There is no evidence that factors of implant design, manufacturing or materials were responsible for this clinical situation".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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Patient's left knee dislocated and was treated with closed reduction under anesthesia (b)(6) 2017.Per exam notes: "patient states that he was in his recliner this morning and when he went to get up his knee popped, immediate pain, and can not bear weight.He also twisted his ankle last week." patient was due to go to the hospital to address the twisted ankle the afternoon of the day he dislocated.Operative report indicates dislocation was without fracture and that in performing the closed reduction, a "palpable pop" was noted with fluoroscopy revealing "acceptable reduction of the knee dislocation both in ap and lateral planes".
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