MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EIUS UNI KNEE LRG FEM LM/RL; IMPLANT

Catalog Number 66362004

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 02/17/2014

Event Type  Injury  

Event Description

Eius uni knee components were explanted and revised to a total knee on left leg.The reason for revision was progression of disease.

Manufacturer Narrative

It was noted that the device is not available for evaluation due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report.Hospital policy.

Manufacturer Narrative

An event regarding revision surgery involving a eius uni knee lrg fem lm/rl was reported.The event was not confirmed.Device history review: indicated all devices accepted into final stock met specifications.Complaint history review: there have been no other events for the lot referenced.The exact cause of the event could not be determined because no medical records, x-rays or device were provided for evaluation which is needed to determine the root cause for the reported event.

Event Description

Eius uni knee components were explanted and revised to a total knee on left leg.The reason for revision was progression of disease.

• Brand Name: EIUS UNI KNEE LRG FEM LM/RL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3674124
• MDR Text Key: 4346285
• Report Number: 0002249697-2014-00740
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052917
• 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: 02/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2009
• Device Catalogue Number: 66362004
• Device Lot Number: LUSFB
• Other Device ID Number: STERILE LOT E511L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2014
• Initial Date FDA Received: 03/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2004
• 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: 62 YR