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

Model Number	5531-G-511
Medical Device Problem Codes	Fitting Problem (2183); Positioning Problem (3009)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	12/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Poor engagement of the pe on the tibial base.Use of other implant of the same size and thickness to complete surgery.
Additional Manufacturer Narrative
Reported event: 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 with the locking wire was returned for evaluation.The locking wire was returned detached from the insert.The locking wire has scratches and is bent in two places which is indicative of at least partial assembly with the baseplate.Indentations are observed on the posterior aspect of one of the condyles which may be indicative of an obstruction during attempted implantation.There are also impression marks observed on the superior bearing condyle surface and some damage on the anterior aspect of the insert at the locking wire groove, possibly caused during attempted assembly and subsequent removal of the insert.-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: based on the visual inspection of the returned component, the damage observed on the locking wire is consistent with attempted seating of the insert onto the baseplate.The observed damage on the posterior aspect of the insert is indicative of an obstruction during attempted seating of the insert onto the baseplate which would have prevented successful assembly.No further investigation for this event is required at this time.
Event or Problem Description
Poor engagement of the pe on the tibial base.Use of other implant of the same size and thickness to complete surgery.

• 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: 6518460
• Report Number: 0002249697-2017-01358
• Device Sequence Number: 16480019
• Product Code: MBH
• UDI-Device Identifier: 07613327045864
• UDI-Public: (01)07613327045864(11)160713(17)210731(10)LFD359
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2017

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: 07/31/2021
• Device Model Number: 5531-G-511
• Device Catalogue Number: 5531G511
• Device Lot Number: LFD359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 07/07/2017
• 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