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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.

Event Description

It was reported that the ball bearing from the provisional shim became disassembled during ultrasonic cleaning.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g4, g7, h2, h3, h6, h7, h9, h10.The product was evaluated through manufacturing review, however, the reported event was unable to be confirmed.The device history records were reviewed and no discrepancies were identified.A corrective and preventative action investigation into this issue was 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.This device was manufactured prior to the design modification and therefore the root cause is the previously addressed 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed.The returned provisional shim exhibited signs of repeated use (nicked/gouged) and one ball bearing and spring were disassembled from the device.The root cause remains unchanged at this time.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: PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 14MM
• Type of Device: PROVISIONAL, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10425656
• MDR Text Key: 203499866
• Report Number: 0001822565-2020-02983
• 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: company representative,foreig
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

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: 62531659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 09/16/2020; 01/28/2021
• Supplement Dates FDA Received: 09/22/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1052-2015
• Patient Sequence Number: 1