MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR-FLEX ART SURF IMPLANT KIT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Birth: (b)(6).Concomitant medical products: 00598005702, 63117084, stemmed tibial component precoat size 8 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten 00595001701, 64086792, femoral component precoat size g left.Report source: foreign country : (b)(4).Customer 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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2019 - 00789.
Event or Problem Description
It was reported that during left knee surgery, the inlay on the tibial tray could not be set correctly; it could not be securely fixed.The surgery was completed with a second device.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product/ provided pictures shows that the dovetail feature exhibits damage (flared out and compressed).The distal surface exhibits damage in various areas.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.Detailed instructions for inserting the articular surface are provided in (nexgen cr-flex fixed bearing knee surgical technique.The root cause is attributed to use error.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CR-FLEX ART SURF IMPLANT KIT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9252243
• Report Number: 0001822565-2019-04656
• Device Sequence Number: 2993305
• Product Code: JWH
• UDI-Device Identifier: 00889024263697
• UDI-Public: (01)00889024263697
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: 90597005012
• Device Lot Number: 64362097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 03/06/2020
• 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: N/A
• Patient Sequence Number: 1
• Patient Weight: 80