MAUDE Adverse Event Report: ZIMMER INC GENDER SOLUTIONS FEMORAL COMPONENT; KRR

Catalog Number 00592601402

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Information was received from a consumer who is not required to complete form 3500a.(b)(4).Other device used: catalog #00597206632 , nexgen prolong all poly patella, lot #62882840.This report will be amended when our investigation is complete.

Event Description

It is reported that the patient is experiencing postoperative swelling and pain.

Manufacturer Narrative

These devices are used for treatment.No implants or pictures provided; therefore the condition of the components is unknown.Surgical notes were not provided.X-rays were not provided; it is unknown whether the devices were implanted with the correct fit and orientation as per the surgical technique.Compatibility of the devices were reviewed with no issues found.A complaint history search found no other complaints for the associated part/lot combinations.A definitive root cause for the complaint cannot be determined with the information provided.

• Brand Name: GENDER SOLUTIONS FEMORAL COMPONENT
• Type of Device: KRR
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5050805
• MDR Text Key: 24875043
• Report Number: 1822565-2015-01630
• Device Sequence Number: 1
• Product Code: KRR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Report Date: 08/05/2015

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 Catalogue Number: 00592601402
• Device Lot Number: 62806536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2014
• 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 Weight: 95