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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch 3500a will be submitted. 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 while disassembling the jammed articular surface construct the technician fractured the base of articular surface.

Manufacturer Narrative

Cmp-(b)(4). Updated: reported event is considered confirmed as the returned tasp was fractured. Visual examination concludes that the returned device is fractured, tasp eexhibits signs of repeated use(nicked and gouged ) also has fractured on the medial side of the post. All pieces were returned. Fracture analysis of the tasp provisional revealed fracture surface artifacts consistent with bending overload fracture. Device history record was reviewed and no discrepancies were found. Per the instrument/provisional use and care package insert, instruments should be carefully inspected before each use and should not be used if the instruments are marred or worn. The package insert also states that breakage can occur if the instruments are subjected to high loads or impactions. The root cause is considered to be operational context as the device was difficult to disassemble due to being jammed with tissue from use. 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

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

• Brand Name: PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL
• 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: 7150232
• Report Number: 0001822565-2017-08687
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 42517600707
• Device Lot Number: 62836961
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Removal/Correction Number: N/A