MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 13 MM THICKNESS; PROSTHESIS, KNEE

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 05/26/2020

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 that the shim was damaged.There was no patient involvement.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Verified item lot combination and reviewed manufacturing date as returned item exhibits signs of repeated use and has both of components disassembled / missing the components were not returned.The device history records & receiving inspection report were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.This device is confirmed to have been a part of the capa 997 investigation.Field action zfa 2014-67 and z-1052-2015 were initiated to recommend against using ultrasonic cleaning as a sterilizing technique for these devices.These devices were subsequently re-designed to account for this failure mode with a new locking mechanism.It was determined that these devices were manufactured prior to this design change.The root cause is considered to be a previously addressed design issue.The following actions were previously initiated to address this issue: capa 997.

Event Description

No additional information.

• Brand Name: TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 13 MM THICKNESS
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10168913
• MDR Text Key: 195612481
• Report Number: 0001822565-2020-02191
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

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: 42527900303
• Device Lot Number: 62436448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 06/23/2020
• Supplement Dates FDA Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: ZFA 2014-67,
• Patient Sequence Number: 1