MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ6 LEFT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5512-F-601

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 12/20/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been two other events for the reported lot.Both relate to the same patient.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

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 again when his knee popped out of place again this morning.He has not been in his knee immobilizer since approximately one week ago".Operative report indicates ".Who had a dislocation approximately 2 weeks ago [event reported for (b)(6) 2017] that was closed reduced.He wore a knee immobilizer for a week, and then today, he was sitting in his chair with his leg in an awkward position, flexed it, and it dislocated again.".Subsequent imaging reported "both ap and lateral planes revealed acceptable reduction of the knee replacement".

Manufacturer Narrative

An event regarding dislocation involving a triathlon femoral component was reported.The event was confirmed.Confirmed: through review of the provided medical records and x-rays by a clinical consultant.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant 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."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." the consulting clinician clarified that this conclusion reflects an alignment issue of the tibial baseplate and femoral component leading toward subsequent subluxation and dislocation.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been two other similar events for the reported lot.Conclusion: clinician review of the medical records provided indicated "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.The consulting clinician clarified that this conclusion reflects an alignment issue of the tibial baseplate and femoral component leading toward subsequent subluxation and dislocation." no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

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 again when his knee popped out of place again this morning.He has not been in his knee immobilizer since approximately one week ago".Operative report indicates ".Who had a dislocation approximately 2 weeks ago [event reported for (b)(6) 2017] that was closed reduced.He wore a knee immobilizer for a week, and then today, he was sitting in his chair with his leg in an awkward position, flexed it, and it dislocated again.".Subsequent imaging reported "both ap and lateral planes revealed acceptable reduction of the knee replacement"."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." the consulting clinician clarified that this conclusion reflects an alignment issue of the tibial baseplate and femoral component leading toward subsequent subluxation and dislocation.

• Brand Name: TRI TS FEMUR SZ6 LEFT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7574398
• MDR Text Key: 110262841
• Report Number: 0002249697-2018-01723
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327026597
• UDI-Public: 07613327026597
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 5512-F-601
• Device Lot Number: THUV
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 117