MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIALL SURFACE PROVISIONAL; KNEE PROSTHESIS

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filled for this event: 0001822565-2018-04579, 0001822565-2018-04580.

Event Description

It was reported that the device had a missing component post surgery.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination concludes that the returned device exhibits signs of repeated use (nicked or gouged) and one has missing component.The missing component is not returned.Dhr was reviewed and no discrepancies were found.The fractured tasp component in this complaint was manufactured before the design modification.The root cause is considered to be a 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.

• Brand Name: PERSONA TIBIALL SURFACE PROVISIONAL
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7821985
• MDR Text Key: 118393207
• Report Number: 0001822565-2018-04581
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42527900501
• Device Lot Number: 62759781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/28/2018
• Supplement Dates Manufacturer Received: 11/15/2018
• Supplement Dates FDA Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1