MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR); PROSTHESIS KNEE

Model Number N/A

Device Problem Device Expiration Issue (1216)

Patient Problem No Code Available (3191)

Event Date 02/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.

Event Description

It was reported that the surgeon implanted expired product during surgery.Subsequently, the patient is experiencing an unknown issue.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable as device was sterile when implanted.Updated:.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR)
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7346183
• MDR Text Key: 102707047
• Report Number: 0001822565-2018-01564
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 42512000414
• Device Lot Number: 62280946
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2013
• 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
• Patient Age: 70 YR