MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER PERSONA TIBIAL INSERTER SIZE E-F; PROSTHESIS, KNEE INSTRUMENT

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed,a supplemental medwatch 3500a will be submitted.

Event Description

It was reported the inserter did not fully seat the implant, was bulkier than the normal inserter, and therefore the implant was seated with the normal inserter.Attempts have been made and additional information on the reported event is unavailable at this time.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable as no adverse event has been previously reported as a result of this malfunction.

• Brand Name: ZIMMER PERSONA TIBIAL INSERTER SIZE E-F
• Type of Device: PROSTHESIS, KNEE INSTRUMENT
• 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: 6859329
• MDR Text Key: 85932903
• Report Number: 0001822565-2017-06333
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 42539809205
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 11/06/2017; 11/07/2017
• Supplement Dates FDA Received: 11/07/2017; 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1