MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #2 RM/LL -8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5630-G-228

Device Problems Break (1069); Crack (1135); Material Integrity Problem (2978); Positioning Problem (3009)

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

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The insert did not seat properly on the tibial tray and it broke during insertion.

Manufacturer Narrative

An event regarding damage involving an triathlon insert was reported.The event was confirmed.Method & results: device evaluation and results: damage observed in the insert consistent with contact against a hard object and explantation.Visual inspection of the returned device confirms that the device was damaged on both sides at the time of implantation.Machine markings are still present.Medical records received and evaluation: there is no indication that patient factors contributed to the reported event.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: visual inspection of the returned device confirms that the device was damaged on both sides at the time of implantation.Material analysis indicated damage observed in the insert consistent with contact against a hard object and explantation.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.

Event Description

The insert did not seat properly on the tibial tray and it broke during insertion.

• Brand Name: TRIATHLON PKR INSERT X3 #2 RM/LL -8MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6503767
• MDR Text Key: 73379679
• Report Number: 0002249697-2017-01296
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 07613327015904
• UDI-Public: (01)07613327015904(11)161004(17)211031(10)2L5YVW
• Combination Product (y/n): N
• PMA/PMN Number: K082567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• 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: 5630-G-228
• Device Lot Number: 2L5YVW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2016
• 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