MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN COMPLETE KNEE SOLUTION; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	00588006012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item# 00588001602; lot# 64121080 item# 00598802015; lot# 63655519 item# 00588000400; lot# 64074708 item# 00598802011; lot# 64105092 g2: foreign - event occurred in australia customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was not returned by the hospital.The investigation is in process.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.
Event or Problem Description
It was reported the patient underwent a right knee revision approximately five (5) years post-implantation due to pain and laxity.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (right knee arthroplasty components are anatomically aligned.There is no fracture, implant loosening or other abnormality.Bone quality is osteopenic).Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.This complaint cannot be confirmed.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19483545
• Report Number: 0001822565-2024-01906
• Device Sequence Number: 7924513
• Product Code: JWH
• UDI-Device Identifier: 00889024199422
• UDI-Public: (01)00889024199422(17)240430(10)64372821
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 00588006012
• Device Lot Number: 64372821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 83 KG