MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Pitted (1460); Naturally Worn (2988)

Patient Problems Pain (1994); No Information (3190)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item # 00598604701 lot # 62460320.Report source: the event occurred in (b)(6).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: 0002648920-2019-00691.

Event Description

It was reported that patient had a total knee arthroplasty and subsequently had a revision due to loosening, subsidence of the tibia, and the polyethylene liner show some backside wear, as well as some pitting on the superior surface.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Item # 66022663.Lot # 82154454.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: 0001822565-2019-04391.

Event Description

It was reported that the patient was also experiencing pain.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Complaint sample was evaluated and the reported event was not confirmed.Nick, gouge, wear, and scoring mark were identified on the tibial plate.No bone cement was adhered to the tibial plate.Pitting, wear, and some micromotion marks on the backside of articular surface were identified on the articular surface.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.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.

• Brand Name: NEXGEN ARTICULAR SURFACE 10 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9082732
• MDR Text Key: 159007405
• Report Number: 0001822565-2019-04061
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K003910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00595204010
• Device Lot Number: 63055535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2020
• 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