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

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 05/08/2019

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.Concomitant medical products: tasp item # 42525900502 lot # 62213209.Tasp item # 42527900502 lot # 62836509.Tasp item # 42527900503 lot # 62565105.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02399, 0001822565-2019-02401, 0001822565-2019-02402.

Event Description

It was reported that persona tray on office shelf had missing shim ball bearings.No patient involved.

Manufacturer Narrative

(b)(4).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 tasp shim exhibits signs of repeated use (nicked or gouged) and has one of components 1 and 2 each disassembled and or missing.Device history record was reviewed and no discrepancies were found.Surgical notes were not provided.Root cause was determined to be associated with the design of the device and was subsequently redesigned.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 SIZE CD 14 MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8697082
• MDR Text Key: 148069646
• Report Number: 0001822565-2019-02400
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• 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: 62449208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1052-2015
• Patient Sequence Number: 1