MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LPS-FLEX FXD MLD EF/3-4 10MM; PROSTHESIS, KNEE

Catalog Number	00596403210
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Arthritis (1723); Pain (1994); Ambulation or Postural Difficulties (2544); Hyperextension (4523); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; b6; b7; d2; g1; g3; g6; h1; h2; h6 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was further reported that the patient was experiencing post-op pain, swelling, and instability and was having a general difficulty ambulating prior to the revision surgery.Attempts have been made and all available information has been provided.
Event or Problem Description
It was reported that a patient had an initial right total knee arthroplasty.Subsequently, the patient was revised approximately 27 months post-op due to pain.During surgery, the poly appeared oxidated and was exchanged.Native patellar eburnation was also identified and a patellar implant was cemented into place.The tibial and femoral components were found well fixed and left intact.No intra-op complications were identified.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 00596401552 - femoral component option size e right compatible with lps-flex prolong - 63118997.00598003702 - stemmed tibial component precoat size 4 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten - 63535344.00596009900 - taper stem plug - 63558546.3003940002 - refobacin bone cement r 2x40g - a640aj1701.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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 event is confirmed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records provided and reviewed state that the patient underwent a right total knee arthroplasty revision due to persistent pain following the initial tka.Preoperatively, the patient reported severe anterior knee pain interfering with sleep, swelling, and general difficulty ambulating.Intraoperatively, patellar eburnation was noted throughout the patella, consistent with degenerative osteoarthritis.The femoral and tibial components were well-fixed and retained.The polyethylene insert was removed due to mild yellow discoloration consistent with oxidative damage, but no pitting or delamination.No signs of infection and flexion and extension gaps appeared symmetric.No intraoperative complications occurred.A definitive root cause cannot be determined.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 FXD MLD EF/3-4 10MM
• 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: 22940101
• Report Number: 0001822565-2025-03222
• Device Sequence Number: 21312164
• Product Code: JWH
• UDI-Device Identifier: 00889024211889
• UDI-Public: (01)00889024211889(17)250331(10)63613720
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2026

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: Lay User/Patient
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 00596403210
• Device Lot Number: 63613720
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 01/26/2026
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/10/2025; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Race: White