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-402
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Injury (2348)
Date of Event	07/26/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Postoperative diagnosis: patient underwent right knee replacement (b)(6) 2013.Patient fell directly on her right knee.Patient underwent right total knee revision due to periprosthetic femur fracture (b2) right knee (b)(6) 2013.Only femur and liner exchanged.
Additional Manufacturer Narrative
An event regarding a periprosthetic fracture involving a triathlon femoral component was reported.The event was confirmed based on x-rays provided.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.-clinician review: the provided documents were rejected for medical review.The following comment was provided: provided x-ray confirms the periprosthetic fracture.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment.Provided x-ray confirms the periprosthetic fracture.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.While the event could be confirmed, further information such as operative reports, office/clinical reports, serial x-rays, and examination of the explanted components are required to complete the investigation for determining a root cause.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
Postoperative diagnosis: patient underwent right knee replacement (b)(6) 2013.Patient fell directly on her right knee.Patient underwent right total knee revision due to periprosthetic femur fracture(b2) right knee 7/26/2013.Only femur and liner exchanged.

• 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: 8361402
• Report Number: 0002249697-2019-01143
• Device Sequence Number: 16634180
• Product Code: MBH
• UDI-Device Identifier: 07613327050370
• UDI-Public: 07613327050370
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

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: 05/31/2018
• Device Catalogue Number: 5515-F-402
• Device Lot Number: IKYRD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/24/2019
• 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: 71 YR
• Patient Weight: 84