MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520B500

Device Problem Migration (4003)

Patient Problem Injury (2348)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: triathlon ps fem component, cemented; cat#: 5515-f-401; lot#: se74r.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.Device not returned.

Event Description

Revision surgery: chronic gonalgia in outcome of arthrosurface cfm patient underwent the first left knee arthroplasty implant due to a gonarthrosis.Updated by qs on 13-nov-2019: per provided medical review comment: x-ray dated (b)(6) 2019 is an ap of the left knee - patella not visualized, a primary tka is in place with no visible cement with the tibial component subsided medially resulting in a varus deformity of the knee.

Manufacturer Narrative

An event regarding subsidence involving a triathlon baseplate was reported.The event was confirmed via medical review.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photos show a cleaned explanted baseplate.Bone cement was observed on it.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: " x-ray dated on (b)(6) 2019 is an ap of the left knee, patella not visualized, a primary tka is in place with no visible cement with the tibial component subsided medially resulting in a varus deformity of the knee.No clinical or pmh, no operative reports, no confirmation of inexplicable and confusing event description.No report possible." product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's left knee was revised due to pain.A review of the provided medical records revealed that a primary tka was in place with no visible cement with the tibial component subsided medially resulting in a varus deformity of the knee.The exact cause of the event could not be determined because insufficient information was provided.Further information such as clarification of the event description, clinical or patient medical history, and operative reports are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Revision surgery: chronic gonalgia in outcome of arthrosurface cfm.Patient underwent the first left knee arthroplasty implant due to a gonarthrosis.Updated by qs on 13-nov-2019: per provided medical review comment: x-ray dated on (b)(6) 2019 is an ap of the left knee, patella not visualized, a primary tka is in place with no visible cement with the tibial component subsided medially resulting in a varus deformity of the knee.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #5
• 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: 9452724
• MDR Text Key: 184866468
• Report Number: 0002249697-2019-04002
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041057
• UDI-Public: 07613327041057
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2012
• Device Catalogue Number: 5520B500
• Device Lot Number: SFCXC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR