MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING CR-FLEX FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Thrombosis (2100)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation; as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant medical products: nexgen poly patella item # 00597206535 lot # 64080689.Nexgen tibial component item # 0059860701 lot # 64069081.Nexgen articular surface item # 90597005010 lot # 64000448.Unknown refobacin cement.Report source: foreign - (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00183, 0002648920-2019-00184, 0001822565-2019-01087.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

It was reported that the patient underwent a knee arthroplasty.Subsequently, approximately seven days post-implantation the patient had a cardiac arrhythmia, deep vein thrombosis (dvt).

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d11, g4, g7, h1, h2, h3, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical information via joint assist was provided and reviewed by a health care professional.A review of the available records identified no complications noted during the surgery.The reported dvt issue is related to the procedure, not implants.No failure detected related to the implants.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

Adverse event was resolved approximately one month later.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING CR-FLEX FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8419672
• MDR Text Key: 138759777
• Report Number: 0001822565-2019-01086
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K031061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00595201701
• Device Lot Number: 64134254
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: NEXGEN TIBIAL PN 00598605701, LN 64069081.
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 84