MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G511
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
Patient was being revised for flexion instability.Femur was revised and replaced with ts femur.Poly had significant damage to it at 9 months post op.
Additional Manufacturer Narrative
An event regarding revision due to flexion instability involving a triathlon insert was reported.The event was not confirmed.Method and results: -device evaluation and results: mar indicated: explantation damage and tibial tray impressions were observed.Burnishing, scratching and third body indentation patterns were observed on the articulating surface.These are consistent with commonly identified damage modes in uhmwpe inserts.The impressions on the underside of the insert caused by the baseplate would be an indication of high compression forces through the knee joint, however, no patient details i.E.Weight/activity level have been received.-medical records received and evaluation: not performed as no medical records were received.-device history review: the device was manufactured and accepted into final stock with no reported 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 for review.Further information such as pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.In relation to the damage 9 months post op to the insert based on the material analysis report (mar) provided, " in-vivo service related damages to the articulating surface of the insert including burnishing, scratching and third body indentations were observed.These are commonly identified damage modes on uhmwpe inserts." no further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
Patient was being revised for flexion instability.Femur was revised and replaced with ts femur.Poly had significant damage to it at 9 months post op.

• Brand Name: X3 TRIATHLON CS INSERT #5 11MM
• 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: 6254527
• Report Number: 0002249697-2017-00230
• Device Sequence Number: 43054
• Product Code: MBH
• UDI-Device Identifier: 07613327045864
• UDI-Public: (01)07613327045864(11)160225(17)210228(10)LEX472
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2017

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: 02/28/2021
• Device Catalogue Number: 5531G511
• Device Lot Number: LEX472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2017
• Supplement Report FDA Received Date: 05/19/2017
• 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: 48 YR