MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 5 LEFT; IMPLANT

Catalog Number 5541-A-501

Device Problems Loose or Intermittent Connection (1371); Delivered as Unsterile Product (1421); Material Perforation (2205)

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

Event Date 07/15/2014

Event Type  malfunction  

Event Description

It was reported patient had revision (not stryker devices) of left knee due to loosening.The internal sterile packaging of a size 5, 10mm left distal femoral augment was perforated.It was determined that the component was unsterile.It could not be used in the surgery and was discarded.(sales rep also noted that external packaging was intact).

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Visual, dimensional and functional analysis could not be performed as the returned device has been misplaced.The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as the device has been misplaced and is not available for evaluation by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

It was reported patient had revision (not stryker devices) of left knee due to loosening.The internal sterile packaging of a size 5, 10mm left distal femoral augment was perforated.It was determined that the component was unsterile.It could not be used in the surgery and was discarded.(sales rep also noted that external packaging was intact).

• Brand Name: TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 5 LEFT
• 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: 3970129
• MDR Text Key: 16175021
• Report Number: 0002249697-2014-02949
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070095
• 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: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• 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: 5541-A-501
• Device Lot Number: XOTD
• Other Device ID Number: STERILE LOT# MSHJJ14A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2010
• 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
• Patient Age: 79 YR
• Patient Weight: 84