MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS #1 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G111
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A 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 available.
Event or Problem Description
It was reported by the sale rep that small gap was found in between tibia tray and tibia insert after the insert was log in to the tibia tray new tibia insert was used to completed the case.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a triathlon insert was reported.The event was confirmed based on the images provided.Method & results -product evaluation and results: visual inspection of the returned device noted the following: damage consistent with the implantation/explantation process was observed on the anterior region and articulating surface.Nothing noteworthy was observed on the surface of the locking wire.No materials or manufacturing discrepancies were observed on the surfaces examined.-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: an intraoperative photograph was provided which confirms the gap between the insert and baseplate components.Visual inspection of the returned device noted the following: damage consistent with the implantation/explantation process was observed on the anterior region and articulating surface.Nothing noteworthy was observed on the surface of the locking wire.No materials or manufacturing discrepancies were observed on the surfaces examined.While the event was confirmed based on the provided images, the exact cause of the event could not be determined, it is not known if any intraoperative event took place which may have resulted in the seating/locking issue.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported by the sale rep that small gap was found in between tibia tray and tibia insert after the insert was log in to the tibia tray new tibia insert was used to completed the case.

• Brand Name: X3 TRIATHLON CS INS #1 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: 8920707
• Report Number: 0002249697-2019-02935
• Device Sequence Number: 11442145
• Product Code: MBH
• UDI-Device Identifier: 07613327045598
• UDI-Public: 07613327045598
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 5531G111
• Device Lot Number: LFK898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 10/31/2019
• 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: Other
• Patient Age: 69 YR