MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5521-B-500
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding malposition involving a triathlon baseplate 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 or Problem 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".

• Brand Name: TRI TS BASEPLATE SIZE 5
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7717953
• Report Number: 0002249697-2018-02286
• Device Sequence Number: 1120257
• Product Code: MBH
• UDI-Device Identifier: 07613327026320
• UDI-Public: 07613327026320
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 5521-B-500
• Device Lot Number: AHB3TA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 117