MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODIFIED HOLLOW PS TIBIAL INSERT TRIAL #4 - 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532-T-411A

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Dr.(b)(6) cracked the bottom of the 4x11 ps poly while using a freer to separate it from the baseplate.Dr.Was finished with his trialing so no time was lost.

Manufacturer Narrative

An event regarding cracked triathlon insert trail was reported.The event was confirmed.Method and results: device evaluation and results: a visual inspection confirms the reported damage.Medical records received and evaluation: not performed as clinical factors did not contribute to the event.Device history review: all devices accepted into final stock conformed to specification.Complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation concluded that the reported event occurred as a result of multiple overload conditions during trialing.Nc was raised due to an exceeded complaint rate for crack/fracture/wear/damage for triathlon modified insert trials, catalogs: 5530-t-xxxa and 5532-t-xxxa.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened and re-evaluated.

Event Description

Dr.(b)(6) cracked the bottom of the 4x11 ps poly while using a freer to seperate it from the baseplate.Dr.Was finished with his trialing so no time was lost.

• Brand Name: MODIFIED HOLLOW PS TIBIAL INSERT TRIAL #4 - 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5355270
• MDR Text Key: 35684984
• Report Number: 0002249697-2016-00021
• 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: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5532-T-411A
• Device Lot Number: PPM8G04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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