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-602
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Arthritis (1723); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	01/08/2014
Type of Reportable Event	Serious Injury
Additional 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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to "right knee osteoarthritis and right knee total arthroplasty failure or loosening.".
Additional Manufacturer Narrative
At the time the adverse event reporting decision was made, it was not clear which device had loosened, therefore the initial mdr report was filed for the femoral component.It was later discovered that the subject device that caused or contributed to the patient¿s experience was the baseplate only and therefore the investigation for this device deems the femoral component concomitant.Reported event: an event regarding loosening of the tibial component involving a triathlon femoral component was reported.Conclusions: a full investigation was completed for the baseplate within this pi.The medical review indicated that a bone scan was ordered which demonstrates significant uptake in the tibia consistent with loosening.The patient was revised to a stemmed construct.Based on the information provided there is no indication or allegation that device reported in this investigation may have contributed to the event and is therefore considered concomitant.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to "right knee osteoarthritis and right knee total arthroplasty failure or loosening." update: review of medical records confirms revision surgery was carried out for aseptic loosening of a tibial component in a cemented tka.

• 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: 8426529
• Report Number: 0002249697-2019-01358
• Device Sequence Number: 1785145
• Product Code: MBH
• UDI-Device Identifier: 07613327050424
• UDI-Public: 07613327050424
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019

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: 06/30/2016
• Device Catalogue Number: 5515-F-602
• Device Lot Number: GLHBA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 03/16/2019
• Supplement Report FDA Received Date: 08/12/2019
• 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