MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CR#2 11MM; IMPLANT

Catalog Number 5530G211

Device Problems Crack (1135); Noise, Audible (3273)

Event Date 03/01/2010

Event Type  Injury  

Event Description

Patient called and stated prior to her bilateral knee surgeries she could hear her knees "cracking" patient is now saying that she hears her implants making a "cracking" noise.Patient also stated in (b)(6) 2010 "surgeon put in patella's".Patient has tendinitis.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as unknown left knee.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Remains implanted.

Manufacturer Narrative

An event regarding pain involving a x3 triathlon insert cr#2 11mm was reported.The event was confirmed.Device history review: indicated all devices accepted into final stock met specifications.Complaint history review: there have been no other events for the lot referenced.A review of the provided records by a clinical consultant indicated there is no evidence that this patient¿s chronic bilateral knee pain is due to factors of faulty prosthetic design, manufacturing, or materials.Also it was noted that the last documented diagnosis of (b)(6) 2013 was bilateral patellar tendinitis and x-rays on that date demonstrated no prosthetic component related abnormalities.The reported event noted patient hears ¿cracking¿ noise but medical records provided to clinical consultant only noted pain leading to resurfacing of patella was experienced by the patient.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 for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.

Event Description

Patient called and stated prior to her bilateral knee surgeries she could hear her knees "cracking" patient is now saying that she hears her implants making a "cracking" noise.Patient also stated in november 2010 "surgeon put in patella's." patient has tendinitis.

• Brand Name: X3 TRIATHLON INSERT CR#2 11MM
• Type of Device: IMPLANT
• 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3667371
• MDR Text Key: 4319805
• Report Number: 0002249697-2014-00690
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/30/2012
• Device Catalogue Number: 5530G211
• Device Lot Number: LAL079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2007
• 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 Age: 54 YR
• Patient Weight: 82