MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5515-F-302
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	12/03/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding loosening involving a triathlon femoral component was reported.The event was confirmed through clinician review of provided medical records.Method & results : product evaluation and results: not performed as no product was returned for evaluation.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: there is some information available in the medical records to suggest that component malposition has played a relevant role in the failure mode of this triathlon ps arthroplasty due to fixation failure.Lack of x-ray availability at this time prevents to establish this with more certainty.Product history review: indicated 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: a review of the provided medical records and x-rays by a clinical consultant indicated: there is some information available in the medical records to suggest that component malposition has played a relevant role in the failure mode of this triathlon ps arthroplasty due to fixation failure.Lack of x-ray availability at this time prevents to establish this with more certainty.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 or Problem Description
This pi is for right knee.It was reported through the communication of an attorney that allegedly the patient was revised due to a failed right total knee arthroplasty.Update (b)(6) 2019: medical review stated the following: right knee revision surgery was performed on (b)(6) 2018.During revision, both tibial baseplate and femoral component appeared loose and could be removed without undue bone damage.The patellar component was intact without issues and was as such retained.Conclusion of assessment: there is some information available in the medical records to suggest that component malposition has played a relevant role in the failure mode of this triathlon ps arthroplasty due to fixation failure.Lack of x-ray availability at this time prevents to establish this with more certainty.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• 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: 9355096
• Report Number: 0002249697-2019-03843
• Device Sequence Number: 2220103
• Product Code: MBH
• UDI-Device Identifier: 07613327050363
• UDI-Public: 07613327050363
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

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: 07/31/2017
• Device Catalogue Number: 5515-F-302
• Device Lot Number: GXMJD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/21/2019
• 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: 53 YR