MAUDE Adverse Event Report: CAYENNE MEDICAL MIRROR; UNICOMPARTMENTAL KNEE ARTHROPLASTY

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arthralgia (2355)

Event Date 05/16/2016

Event Type  Injury  

Manufacturer Narrative

Explanted implant was not returned.

Event Description

On (b)(6) 2016, cayenne medical was notified that a mirror knee system with possible tibial loosening will be revised to total knee system.On 06/01/2016, cayenne medical received confirmation that the revision occured on (b)(6) 2016.It was also reported that the mirror baseplate was found loose and there was no sign of poly wear or osteolysis.The surgeon commented that the revision was not related to the mirror partial knee system.

• Brand Name: MIRROR
• Type of Device: UNICOMPARTMENTAL KNEE ARTHROPLASTY
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85260
• Manufacturer (Section G): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85255
• Manufacturer Contact: shima hashemian ; 16597 n 92nd street; scottsdale, AZ 85260 ; 4805023661
• MDR Report Key: 5718530
• MDR Text Key: 47188821
• Report Number: 3006108336-2016-00004
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2016

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 Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2016
• Initial Date FDA Received: 06/10/2016
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention