MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL; PROSTHESIS, KNEE

Model Number N/A

Device Problems Component Missing (2306); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional concomitant medical products: tibial articular surface provisional shim size cd 14 mm item # 42527900304 lot # 62414007; tibial articular surface provisional shim size gh 12 mm item # 42527900702 lot # 62220948; tibial articular surface provisional shim size gh 14 mm item # 42527900704 lot # 62784389; tibial articular surface provisional shim size gh 11 mm item # 42527900701 lot # 62756004.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00672, 0001822565-2019-00673, 0001822565-2019-00674, 0001822565-2019-00675.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.

Event Description

It was reported that a tibial articular surface provisional was found worn and the ball bearings were missing.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of product exhibits signs of repeated use (nicked or gouged) and has one of components 1 and 2 disassembled / missing.The missing component was not returned.Device history record was reviewed and no discrepancies were found.Surgical notes were not provided.Root cause was determined in capa investigation to be associated with the design of the device and was subsequently redesigned.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.

• Brand Name: PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8354691
• MDR Text Key: 136768517
• Report Number: 0001822565-2019-00671
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42527900501
• Device Lot Number: 62710614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 05/16/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1052-2015
• Patient Sequence Number: 1