MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #7 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5510-F-702

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

Patient was experiencing pain and swelling.Patient was booked for a tka revision.Upon exposure of the original cr femoral component it was discovered that the femoral implant was broken in two pieces at the posterior lateral femoral condyle.The right femur was removed and replaced with a ts femur.

Event Description

Patient was experiencing pain and swelling.Patient was booked for a tka revision.Upon exposure of the original cr femoral component it was discovered that the femoral implant was broken in two pieces at the posterior lateral femoral condyle.The right femur was removed and replaced with a ts femur.

Manufacturer Narrative

Reported event an event regarding crack/fracture involving a triathlon femoral component was reported.The event was confirmed via photographs.Method & results -product evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted triathlon femoral component with biological material throughout and one condyle was broken off.From the photographs provided there is evidence of crack/fracture for the device.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes 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.

• Brand Name: TRIATHLON CR FEM COMP #7 R-CEM
• 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: 10580002
• MDR Text Key: 208328899
• Report Number: 0002249697-2020-01976
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040357
• UDI-Public: 07613327040357
• 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
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: 5510-F-702
• Device Catalogue Number: 5510F702
• Device Lot Number: SR3PJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 54