MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #6 PS INSERT 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532P611

Device Problems Failure to Align (2522); Device Operates Differently Than Expected (2913); Mechanical Jam (2983); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2016

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Per sales rep 12/13/2016: the were not broken but were both malalligned upon impaction.They were not able to lock in.The surgeon tried three times.

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 posterior tab and edge of the retaining slot wall on inferior surface of the insert all show damage consistent with the insert having been incorrectly presented to the baseplate during assembly.It would appear that the plastic tabs were pressed against the front end of the metal retaining tabs of the baseplate rather than underneath the metal tabs.The observed damage on the locking wire is indicative of attempted assembly of the insert onto the baseplate.Medical records received and evaluation: not performed as no medical records were provided.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 observed damage on the posterior aspect and inferior edge of the retaining slot wall of the insert is indicative of an obstruction during attempted seating of the insert onto the baseplate.The observed damage on the locking wire is indicative of attempted assembly of the insert onto the baseplate.No further investigation for this event is required at this time.

Event Description

Per sales rep (b)(4) 2016: they were not broken but were both malalligned upon impaction.They were not able to lock in.The surgeon tried three times.

• Brand Name: TRIATHLON #6 PS INSERT 11MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6234496
• MDR Text Key: 64586838
• Report Number: 0002249697-2017-00137
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 5532P611
• Device Lot Number: LFH942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2016
• Initial Date FDA Received: 01/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other