MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SIZE 3-5 EF TOP; PROVISIONAL, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The 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 or Problem Description
It is reported that the provisional was returned fractured.Attempts have been made to obtain additional information, however, no additional information is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, e1, g4, g7, h1, h2, h3, h6, h7, h9, h10 the complaint sample was evaluated and the reported event was confirmed through physical evaluation.The returned provisional exhibits signs of repeated use (nicked or gouged) the dovetail feature is compressed & is fractured on the medial side of post, not all pieces returned.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Capa (b)(4) investigation into this issue determined that the likely root cause for the tasp fractures is bending/torsional loading on the device.A notification was sent to the field on (b)(6), 2014 to provide additional clarifications relating to the instructions for use of the tasp construct for all persona users on file at the time of the field notice.Ps tasp top components and standard (non-cps) tasp bottom components have been modified to prevent fracture.The fractured tasp component in this complaint was manufactured before the design modification and therefore the root cause is considered to be a previously addressed design issue.

• Brand Name: PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SIZE 3-5 EF TOP
• Common Device Name: PROVISIONAL, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10010147
• Report Number: 0001822565-2020-01580
• Device Sequence Number: 16329087
• Product Code: JWH
• UDI-Device Identifier: 00889024238817
• UDI-Public: (01)00889024238817
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42517400610
• Device Lot Number: 62565041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2578-2014
• Patient Sequence Number: 1