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

Model Number N/A

Device Problem Component Missing (2306)

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

Event Date 07/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).0001822565 - 2018 - 04106 , 0001822565 - 2018 - 04107, 0001822565 - 2018 - 04108, 0001822565 - 2018 - 04109, 0001822565 - 2018 - 04110, 0001822565 - 2018 - 04111, 0001822565 - 2018 - 04105, 0001822565 - 2018 - 04113.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 tasp shim was worn and returned, found missing one or both ball bearings.No patient involvement was reported.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device identified signs of repeated use and has components missing.Device history record (dhr) was reviewed and no discrepancies were found.The root cause was determined to be design deficiency.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.

• Brand Name: TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 12 MM THICKNESS
• Type of Device: TEMPLATE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7743176
• MDR Text Key: 115907046
• Report Number: 0001822565-2018-04112
• 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: 05/01/2019

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: 42527900702
• Device Lot Number: 62677157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1