MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CR#2 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5530G209
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Rep reported the spring mechanism failed during a primary right knee surgery.A replacment device was available, no delay or consequence to the patient.
Additional Manufacturer Narrative
An event regarding a seating/locking issue involving a triathlon insert was reported.The event was confirmed by visual inspection.Method & results: -device evaluation and results: the insert was returned without the locking wire.The posterior tab of the insert show damage consistent with the insert having been incorrectly presented to the baseplate during assembly whereby the plastic tabs were pressed against the front end of the metal retaining tabs of the baseplate rather than underneath the metal tabs.Evidence of explantation damage is also noted throughout the device including the anterior face and locking wire retention groove.-medical records received and evaluation: not performed as the reported component was not implanted.-device history review: dhr review for the reported lot was satisfactory.-complaint history review: chr review for the reported lot confirmed that there are no other similar events reported.Conclusions: the reported event describes an issue with the spring mechanism of an insert while attempting to seat the insert on the baseplate.Based on the visual inspection of the returned component, the observed damage on the posterior aspect of the insert is indicative of an obstruction during attempted seating of the insert onto the baseplate.The observed damage on the anterior face is indicative of attempted assembly of the insert onto the baseplate and subsequent removal of same.Incorrectly seating the insert may have caused the locking wire to come in contact with the baseplate in a manner that would have caused it to detach from the insert resulting in the reported spring mechanism failure.
Event or Problem Description
Rep reported the spring mechanism failed during a primary right knee surgery.A replacment device was available, no delay or consequence to the patient.

• Brand Name: X3 TRIATHLON INSERT CR#2 9MM
• 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: 6272895
• Report Number: 0002249697-2017-00317
• Device Sequence Number: 18965135
• Product Code: MBH
• UDI-Device Identifier: 07613327046410
• UDI-Public: (01)07613327046410(11)160203(17)210228(10)LEW705
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2017

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: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 5530G209
• Device Lot Number: LEW705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2017
• Supplement Report FDA Received Date: 03/28/2017
• 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: Other
• Patient Age: 55 YR