MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; IMPLANT

Catalog Number 5530-G-509

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Injury (2348)

Event Date 03/29/2014

Event Type  Injury  

Event Description

It was reported that patient came to surgeon with open wound post op 4 weeks and was referred to vascular consult didn't clear, so surgeon did revision poly exchange and debridement.

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown poly.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

The following product was added to the complaint after the initial medwatch was submitted.At this time, it cannot be determined if these devices may have caused or contributed to the patient¿s experience.Cat.No.: 5510-f-601, triathlon cr fem comp #6 l-cem, lot code: ecejf.Cat.No.: 5520-b-500, triathlon prim cem fxd bplt #5, lot code: ebhtk.Cat.No.: 5550-g-319, triathlon symmetric x3 patella, lot code: y38a.The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.A capa trend analysis was conducted for the reported failure mode and concluded infection 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 insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

It was reported that patient came to surgeon with open wound post op 4 weeks and was referred to vascular consult didn't clear so surgeon did revision poly exchange and debridement.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: 3756385
• MDR Text Key: 4483379
• Report Number: 0002249697-2014-01260
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 5530-G-509
• Device Lot Number: MMM32N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2013
• 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: 60 YR
• Patient Weight: 83