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

Model Number N/A

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been returned and investigation is in progress.Once the investigation is complete and follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001822565 -2019 - 00288.

Event Description

It was reported that the tibial articular surface provisional was returned with missing components.No additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product confirms the reported instrument wear and damage.Review of device history records identified no related manufacturing deviations or anomalies.It is known the device was manufactured prior to design improvements.The root cause is attributed to design.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 information available at the time of this reporting.

• Brand Name: TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 14 MM THICKNESS
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8264929
• MDR Text Key: 133771193
• Report Number: 0001822565-2019-00289
• Device Sequence Number: 1
• Product Code: MBH
• 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
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

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: 42527900304
• Device Lot Number: 62229780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/21/2019
• Supplement Dates Manufacturer Received: 05/15/2019
• Supplement Dates FDA Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: ZFA 2014-67 AND Z-1052-2
• Patient Sequence Number: 1