MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT PS#2 13MM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number 5532G213

Device Problem Insufficient Information (3190)

Patient Problems Scarring (2061); Injury (2348)

Event Date 09/08/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the patient and was not returned to the manufacturer.Additional information has been requested but not made available due to hospital policy.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Due to scaring the insert was removed and replaced with a new insert.

Manufacturer Narrative

An event regarding revision for scaring involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no devices were returned.Medical records received and evaluation: not performed as no medical records were provided for review.Device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the exact cause of the event could not be determined as insufficient information was provided.Further information such as device return, x-rays and operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation for this event is possible at this time as no devices and insufficient information were received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

Due to scarring the insert was removed and replaced with a new insert.

• Brand Name: X3 TRIATHLON INSERT PS#2 13MM
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick 00000
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5128035
• MDR Text Key: 27488072
• Report Number: 0002249697-2015-03249
• 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: Followup
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 5532G213
• Device Lot Number: LDA732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2012
• 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: 65 YR
• Patient Weight: 70