MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX ARTICULA; PROSTHESIS, KNEE

Catalog Number 00596405010

Device Problems Pitted (1460); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Unspecified Infection (1930)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made and additional information on the reported event is unavailable at this time.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.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03625, 0001822565-2018-03627.

Event Description

It was reported that the patient was experiencing aseptic loosening post total knee arthroplasty and underwent a first stage knee revision due to infection approximately four years post implantation.It was noted that the polyethylene bearing showed signs of wear and pitting.No additional information is available.

Manufacturer Narrative

(b)(4).Concomitant medical products - femoral size g, lt part # 00596401751, lot # 62254530, tibial plate, size 8 (blue/str blue) part # 00598005702, lot # 62133498, all-poly patella, 38mm x 9.5mm part# 00597206538, lot# 62413073, refobacin bone cement r part # 3003940002 lot # 235bae2108.Report source foreign - (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.No devices were received; therefore, the condition of the components is unknown.Surgical notes were not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.However, 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.

Event Description

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

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX ARTICULA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7679497
• MDR Text Key: 113711448
• Report Number: 0001822565-2018-03628
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K991581
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 00596405010
• Device Lot Number: 62412557
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN FEMUR; UNKNOWN TIBIA; UNKNOWN FEMUR; UNKNOWN TIBIA
• Patient Outcome(s): Hospitalization; Required Intervention