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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Joint locking (2672); Joint Laxity (4526)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure post implantation due to fractured articular surface.No more information is available.
Additional Manufacturer Narrative
(b)(4).H3: the complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.D10 - medical product: femoral component option size d left compatible with lps-flex prolong catalog # 00596401451 lot # 63701175f17.Stemmed tibial component precoat size 5 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten catalog # 00598004701 lot # 63901274.Taper stem plug catalog # 00596009900 lot # 637769269h17.All poly petella standard cemented size 32 mm diameter 8.5 mm thickness catalog # 00597206532 lot # 63795055j17.Palacos rg 1x40 single catalog # 00111314001 lot # 85734578l16.
Event or Problem Description
It was reported patient underwent a revision procedure six years post implantation due to pain and locking of the knee.Upon entering the joint, it was noted that the post on the polyethlene tray appeared to have been sheard off.It was sitting in the join surface.Femur, tibia, and patella were found well intact and remained implanted.Scar tissue excised around the patella and tibia.The polyethylene was exchanged without complications.All other components remain implanted.No more information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a2, b4, b5, g4, g7, h1, h2, h3, h6, h9, h10.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of implantation in the form of discoloration, gouges, and micromotion.The post of the implant was found to be fractured from the body of the device.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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 or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.The implant was submitted for additional further analysis.Analysis determined no visible evidence of delamination along with no evidence of significant oxidation in any of the scans.Slight oxidation at the outer edges of the part, typical of being in-vivo 8 years.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision operative note: exam: unable to extend knee fully and ambulating with partial bent knee, no evidence of infection or loosening by x-rays.Upon entering the joint, noted the "post on the polyethylene tray appears to have been sheard off.It was sitting in the joint surface." femur, tibia, and patella were found well intact and remained implanted.The root cause remains unchanged.If any further information is found 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 LPS-FLEX ARTICULAR SURFACE
• Common Device Name: PROSTHESIS KNEE
• 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: 21104834
• Report Number: 0001822565-2025-00095
• Device Sequence Number: 15647172
• Product Code: JWH
• UDI-Device Identifier: 00889024211322
• UDI-Public: (01)00889024211322(17)210930(10)63492938
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00596204114
• Device Lot Number: 63492938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2024
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 03/12/2025; 05/06/2025; 06/17/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/21/2025; 05/27/2025; 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2016
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 79 KG