MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #6 LM/RL -9MM; IMPLANT

Catalog Number 5630-G-609

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/17/2014

Event Type  Injury  

Event Description

It was reported that the surgeon performed an i and d and swapped the poly due to infection.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device due to hospital policy.Additional information was requested and if it becomes available will be submitted in a supplemental report.Not returned to manufacturer.

Manufacturer Narrative

The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.A review of the device history records could not be performed because the device associated with this event was not returned nor was a valid lot code provided.A review of the complaint databases could not be performed because the device associated with this event was not returned nor was a valid lot code provided.Visual, dimensional and functional analysis could not be performed as the device was not returned.A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.No further investigation for this event is possible at this time as no devices and in sufficient information was received by stryker orthopaedics.

Event Description

It was reported that the surgeon performed an i & d and swapped the poly due to infection.

• Brand Name: TRIATHLON PKR INSERT X3 #6 LM/RL -9MM
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3624544
• MDR Text Key: 4208849
• Report Number: 0002249697-2014-00386
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5630-G-609
• Device Lot Number: MMEJB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 104