MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #1 RM/LL -8MM; IMPLANT

Catalog Number 5630-G-128

Device Problems Labelling, Instructions for Use or Training Problem (1318); Expiration Date Error (2528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional has been requested.Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.

Event Description

It was discovered through the billing process at the branch that the above mentioned implant had expired on may 30, 2015 and was implanted during a surgery that took place on (b)(6) 2015.

Manufacturer Narrative

The event is considered an off label use as the device was reported to have been implanted after the indicated expiration date.The ifu confirmed to have been packaged with the device, qin 4388 version b, provides instructions on how to identify the use by date indicated on the package label.Review of the label applied to the dhr at the time of manufacture indicated the expiration date of the subject implant was correctly described as 2015-05.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was discovered through the billing process at the branch that the above mentioned implant had expired on (b)(6) 2015 and was implanted during a surgery that took place on (b)(6) 2015.

• Brand Name: TRIATHLON PKR INSERT X3 #1 RM/LL -8MM
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5035645
• MDR Text Key: 25107501
• Report Number: 0002249697-2015-02823
• Device Sequence Number: 1
• Product Code: HRY
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 5630-G-128
• Device Lot Number: MJJ37D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2010
• 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