MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G711

Device Problems Material Deformation (2976); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 06/02/2011

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Total knee revision was performed.Date of implant was identified as (b)(6) 2009.

Manufacturer Narrative

An event regarding instability involving an triathlon insert was reported.The event was not confirmed.Device evaluation and results: minor damages were observed on edges.Material analysis engineer indicated that "damage consistent with edge loading from femoral component observed on distal end of articulating surface of insert." explantation damage also observed." medical records received and evaluation: no medical records or x-rays were made available for evaluation.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: it was reported that patient was revised due to flexion instability.The device was returned and damages were observed on edges and articulating surface of insert.As per material analysis engineer these damages are the damage consistent with edge loading from femoral component observed on distal end of articulating surface of insert.Explantation damage were also observed.The event could not be confirmed nor the root cause could be determined because insufficient medical information was provided.If additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Total knee revision was performed.Date of implant was identified as (b)(6) 2009.

• Brand Name: X3 TRIATHLON CS INSERT #7 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6779159
• MDR Text Key: 82332319
• Report Number: 0002249697-2017-02431
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• 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: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2014
• Device Catalogue Number: 5531G711
• Device Lot Number: LBT077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2009
• 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): Hospitalization; Required Intervention
• Patient Age: 46 YR