MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 14 MM THICKNESS; PROSTHESIS, KNEE

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Unique identifier (udi) #: n/a.The 0001822565 - 2018 - 03876, 0001822565 - 2018 - 03877, 0001822565 - 2018 - 03878, 0001822565 - 2018 - 03879.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.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that it was found in an instrument tray on distributor office shelf that articular surface provisional shims with missing ball bearings and a fractured articular surface provisional.

Manufacturer Narrative

(b)(4).0001822565 - 2018 - 03876 - 1, 0001822565 - 2018 - 03877 - 1, 0001822565 - 2018 - 03878 - 1, 0001822565 - 2018 - 03879 - 1.Complaint sample was evaluated and the reported event was confirmed.Device history record was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to design issue.Field actions were initiated to recommend against using ultrasonic cleaning as a sterilizing technique for these devices.The device was subsequently re-designed to account for this failure mode with a new locking mechanism.It was determined that this device was manufactured prior to this design change.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 14 MM THICKNESS
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7785245
• MDR Text Key: 117259595
• Report Number: 0001822565-2018-03875
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

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: 42527900504
• Device Lot Number: 62801254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 08/15/2018
• Supplement Dates Manufacturer Received: 02/11/2019
• Supplement Dates FDA Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1