MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL FEMORAL XT COMPONENT SIZE B; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products: articular surface with segmental hinge post; p/n: unk, l/n: unk, distal femoral xt; p/n: 00585004201, l/n: 63183376, fluted stem extension; p/n: 00585205011, l/n: 63929453, kne-segmental-stems-unk; p/n: unk, l/n: unk.Report source: foreign: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 05444, 0001822565 - 2019 - 05446, 0001822565 - 2019 - 05447, 0001822565 - 2019 - 05448.

Event Description

It was reported patient was revised due to instability.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Updated: a5, b4, b5, d10, g4, g7.Additional: h1, h2, h3, h6, h10.Complaint samples were evaluated and the reported event was confirmed.Visual inspection of the returned femoral component, tibial tray component, and the articular surface all exhibit signs of being implanted, plus they were also returned assembled to each other.The anteversion tabs in the femoral component were fractured upon receiving.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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: DISTAL FEMORAL XT COMPONENT SIZE B
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9521189
• MDR Text Key: 178150734
• Report Number: 0001822565-2019-05447
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00585004201
• Device Lot Number: 63183376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention