MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #2 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G209

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Damage to Ligament(s) (1952); Pain (1994); Injury (2348)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Implanted the triathlon by tka procedure on (b)(6) 2016.Pain occurred behind knee about (b)(6) 2016.It was confirmed pcl tear and unstable insert by an arthroscope.It will be treated by a surgical procedure on (b)(6) 2017.

Manufacturer Narrative

The device did not return.An event regarding instability involving a triathlon insert was reported.The event was not confirmed.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as product lot details, product return, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Not returned.

Event Description

Implanted the triathlon by tka procedure on (b)(6) 2016.Pain occurred behind knee about (b)(6) 2016.It was confirmed pcl tear and unstable insert by an arthroscope.It will be treated by a surgical procedure on (b)(6) 2017.

• Brand Name: X3 TRIATHLON CS INSERT #2 9MM
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6286456
• MDR Text Key: 66053594
• Report Number: 0002249697-2017-00353
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5531G209
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 59