MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G511

Device Problems Material Deformation (2976); Scratched Material (3020); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/15/2010

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) 2010.

Manufacturer Narrative

An event regarding pain involving a triathlon insert was reported.The event was not confirmed.Device evaluation and results: the product was returned in used condition.The images of returned product shows damage on distal end of articulating surface and scraches on many places.Examination of the returned product with material analysis engineer indicated "common damage modes of in-service uhmwpe observed on insert.Explantation damage 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 had revision surgery due to pain.The event could not be confirmed nor could the root cause be determined because insufficient information was provided.The material analysis of returned device indicated that common damage modes of in-service uhmwpe and damage on distal end of articulating surface are observed on insert.Explantation damage was also observed on the product.A capa trend analysis was conducted for the reported failure mode and concluded pain may result from other factors not necessarily related to the device.No further investigation is possible at this time.Further information such as patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

Total knee revision was performed.Date of implant was identified as (b)(6) 2010.

• Brand Name: X3 TRIATHLON CS INSERT #5 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: 6779160
• MDR Text Key: 82332466
• Report Number: 0002249697-2017-02432
• 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: 02/01/2013
• Device Catalogue Number: 5531G511
• Device Lot Number: LAZ781
• 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: 02/01/2008
• 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: 64 YR