MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #2 LM/RL -9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5630-G-209

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976); 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 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

Doctor could not lock insert in place.Opened second poly and it seated.

Manufacturer Narrative

An event regarding seating/locking issues involving an triathlon insert was reported.The event was confirmed.Method and results: device evaluation and results: examination of the device by the mar engineer indicated "the damage observed on the distal surface is consistent with contact against the baseplate.Explantation damage is also observed." medical records received and evaluation: not performed as patient factors did not contributed to the 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: the reported event was confirmed as per consultation of the returned device with material analysis engineer who indicated that damage observed on the distal surface is consistent with contact against the baseplate.Explantation damage is also observed.

Event Description

Doctor could not lock insert in place.Opened second poly and it seated.

• Brand Name: TRIATHLON PKR INSERT X3 #2 LM/RL -9MM
• 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: 6116027
• MDR Text Key: 60559374
• Report Number: 0002249697-2016-03689
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 5630-G-209
• Device Lot Number: MMDN3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2013
• 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: 67 YR
• Patient Weight: 88