MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZES C, D +0 MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination of the returned product identified signs of repeated use (nicked and gouged) and the dove tail feature is damaged on one side with a piece fractured off.All pieces were not returned.Review of the supplier device history record(s) identified no deviations or anomalies during manufacturing.This complaint was confirmed by evaluation of the returned device.A definitive root cause cannot be determined with the information available.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 the bottom tasp has a dent and the dove tail feature is damaged on one side with a piece fractured off.All pieces were not returned.

• Brand Name: TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZES C, D +0 MM
• 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: 11313050
• MDR Text Key: 232451616
• Report Number: 0001822565-2021-00366
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024558144
• UDI-Public: (01)00889024558144(10)64408407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181947
• 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
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• 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: 42589200300
• Device Lot Number: 64408407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1