MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC.

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Inflammation (1932)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is based on a clinical study data review.At this point the investigation is still on going.A supplemental mdr will be completed once the investigation is completed.Not returned.

Event Description

Possibly contact dermatitits on the or staff's right hand with accufill.

• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer Contact: victor krone ; 841 springdale drive; exton, PA 19341 ; 4848794224
• MDR Report Key: 6142190
• MDR Text Key: 61349582
• Report Number: 3008812173-2016-00035
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2016

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: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 402.202
• Device Lot Number: KC03110
• Other Device ID Number: N/A
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention