MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LPS-FLEX ARTICULAR SURFACE; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Unspecified Tissue Injury (4559)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: lps-flex gsf opt sz e-r, catalog #: 00-5764-015-52, lot #: 63099325.St prc tib plt size 3, catalog #: 00-5980-037-01, lot #: 62992024.Stem implant 15mmdx75mm, catalog #: 00-5988-012-15, lot #: 63260059.Unknown bone cement, catalog #: unknown, lot #: unknown.Report source: (b)(6).Customer has indicated that the product will not be returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was revised for an articular surface prosthesis exchange, synovectomy and patella resurfacing.Attempt for further information has been made, but no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.It was noted that the patient was having patellar pain due to pressure on their native patella.This required the patient to undergo a patellar resurfacing procedure during which the poly was revised five years status index procedure.There was no indication or allegation of failure or malfunction related to the poly and the poly was not identified as a contributing factor to the pain being experienced by the patellar pain.Therefore, this revision was related to disease progression of the patella.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
From additional information received, the patella resurfacing surgery was performed due to patella pain from pressure on a previously un-resurfaced patella.

• Brand Name: NEXGEN LPS-FLEX ARTICULAR SURFACE
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11968781
• Report Number: 0001822565-2021-01565
• Device Sequence Number: 16487641
• Product Code: JWH
• UDI-Device Identifier: 00889024211131
• UDI-Public: (01)00889024211131(17)201130(10)63214680
• 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: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00596203210
• Device Lot Number: 63214680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention