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

Catalog Number 5532-T-611A

Device Problems Break (1069); Crack (1135); Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

It was reported that during a right total knee surgery, the surgeon put in trial and checked for range of motion and upon removal of the trial, the trial cracked.No delay or adverse consequence and surgery completed without further incident.

Manufacturer Narrative

An event regarding an alleged fracture involving a triathlon modified insert trial was reported.The event was confirmed.Method and results: device evaluation and results: visual inspection indicated a 1/2 inch long portion of the bottom edge had fractured and separated from the device.An examination of the device by the materials analysis team using a stereo microscope indicated hackles (crack branching) resulting from fast fracture overload had occurred.Medical records received and evaluation: no patient information was provided.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the event was confirmed.Visual inspection indicated a 1/2 inch long portion of the bottom edge had fractured and separated from the device.An examination of the device by the materials analysis team using a stereo microscope indicated hackles (crack branching) resulting from fast fracture overload had occurred.

Event Description

It was reported that during a right total knee surgery, the surgeon put in trial and checked for range of motion and upon removal of the trial, the trial cracked.No delay or adverse consequence and surgery completed without further incident.

• Brand Name: MODIFIED HOLLOW PS TIBIAL INSERT TRIAL #6 - 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5398717
• MDR Text Key: 37104563
• Report Number: 0002249697-2016-00219
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• 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: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2018
• Device Catalogue Number: 5532-T-611A
• Device Lot Number: PPM8G19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other