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

Catalog Number 5532P209

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

During a total knee replacement both femoral and tibial implants were inserted without any problems.While inserting the tibial bearing insert, it would not engage into the tibial tray fully.As a result, the insert was removed and replaced with another, which engaged correctly.

Manufacturer Narrative

An event regarding a seating/locking issue involving a triathlon insert was reported.The event was confirmed by visual inspection.The insert was returned without the locking wire.There is damage on the anterior edge of the device most likely caused during removal of the insert from the baseplate after attempted assembly.There is damage on the posterior aspect of the bearing surface of the device.There is damage present on the anterior outside rim of the bearing surface.There is also damage on the underside of the component on multiple areas.These types of damage are indicative of an obstruction on the posterior aspect of the insert and on the retaining slot of the inferior surface which may have been the reason that the user failed to position the insert correctly on the baseplate.Medical records received and evaluation: not performed as the reported component was not implanted.Dhr review for the reported lot was satisfactory.Chr review for the reported lot confirmed that there are no other similar events reported.Based on the visual inspection of the returned component, the observed damage on the posterior aspect and inferanterior outside rim of the bearing surface of the insert is indicative of an obstruction during attempted seating of the insert onto the baseplate.A capa trend analysis was conducted for the reported failure mode and concluded that seating/locking difficulties may arise from user-related issues associated with the preparation of the joint space prior to the attempted seating and with the technique required to correctly introduce the insert component to the baseplate.No further investigation for this event is required at this time.

Event Description

During a total knee replacement both femoral and tibial implants were inserted without any problems.While inserting the tibial bearing insert, it would not engage into the tibial tray fully.As a result, the insert was removed and replaced with another, which engaged correctly.

• Brand Name: TRIATHLON #2 PS INSERT 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6835504
• MDR Text Key: 84271910
• Report Number: 0002249697-2017-02658
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327042603
• UDI-Public: 07613327042603
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

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: 09/25/2020
• Device Catalogue Number: 5532P209
• Device Lot Number: LEP469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 10/20/2017
• Supplement Dates FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2015
• 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
• Patient Age: 75 YR