MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 12 MM THICKNESS; PROSTHESIS, KNEE

Model Number N/A

Device Problems Corroded (1131); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2019

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.Unique identifier (udi) #: n/a multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 03790, 0001822565 - 2019 - 03792, 0001822565 - 2019 - 03793, 0001822565 - 2019 - 03794, 0001822565 - 2019 - 03795, 0001822565 - 2019 - 03796, 0001822565 - 2019 - 03797, 0001822565 - 2019 - 03798, 0001822565 - 2019 - 03799, 0001822565 - 2019 - 03800.

Event Description

It was reported that multiple provisional shims were found to have missing ball bearings or the ball bearings were rusted in place in a distributor warehouse.No patient involvement.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned device identified signs of repeated use and has missing components.Device history record (dhr) was reviewed and no discrepancies were found.This type of malfunction has been investigated in the past, and it was identified that the ball bearings could disassemble during cleaning.The root cause of the reported issue is attributed to design issue.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: TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 12 MM THICKNESS
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8960016
• MDR Text Key: 156456461
• Report Number: 0001822565-2019-03791
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

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: 42527900502
• Device Lot Number: 62483183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1052-2015
• Patient Sequence Number: 1