MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PS TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE 6-9 GH TOP; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Naturally Worn (2988)

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

Event Date 12/09/2020

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.

Event Description

It was reported via worn instrument return form that the trial articular surface was returned fractured.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned device exhibits signs of repeated use (nicked or gouged) the dovetail feature is compressed & is fractured on the medial side of post.Device history record (dhr) was reviewed and no discrepancies were found.Previous investigation for this fracturing of this type of device determined that the likely root cause was bending/torsional loading on the device.The root cause is considered to be a previously addressed design issue.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: PS TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE 6-9 GH TOP
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11100554
• MDR Text Key: 224535670
• Report Number: 0001822565-2020-04271
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• 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: 42517400910
• Device Lot Number: 62565108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2578-2014
• Patient Sequence Number: 1