MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN SIZE 5 PRECOAT CEMENTED STEMMED ANTERIOR/POSTERIOR TIBIAL COMPONENT; PROSTHESIS, KNEE

Catalog Number	00598800500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).B3: it was reported that symptom onset began may 2024.D10: concomitant medical product: lcck nexgen right size f cemented option femoral component: catalog#: 00599401692, lot#: 63712895; nexgen distal femoral augment block size f 5mm: catalog#: 00599003610, lot#: 63245944, qty #2; nexgen 17mm diameter 100mm length straight stem extension combined length 145mm: catalog#: 00598801017, lot#: 63641556; nexgen 13mm diameter 30mm length cemented stem extension combined length 75mm: catalog#: 00598801713, lot#: 63739216; trabecular metal tibial cone, medium 36x31mm: catalog#: 00545001336, lot#: 63781592; lcck nexgen 10mm height size e,f with locking screw green articular surface: catalog#: 00599404010, lot#: 62531565; nexgen all poly patella standard cemented size 35 mm diameter 9.0 mm thickness: catalog#: 00597206535, lot#: 63868924; palacos rg 1x40 single bone cement: catalog#: 00111314001, lot#: 86694600, qty#2 the product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon completion of the investigation, a follow-up mdr be submitted.
Event or Problem Description
It was that a patient underwent a revision total knee arthroplasty.Subsequently, six (6) years and four (4) months post-implantation, the patient began experiencing swelling, pain, stiffness, instability, buckling, redness, difficulty walking, and a cracking sound/loud painful pops.Diagnostic imaging was performed and did not reveal loosening of the cemented components.All implants remain implanted and additional medical intervention has not been reported.
Additional Manufacturer Narrative
The following report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10; h11.Visual examination of the provided picture identified a posterior view of a right knee.A vertical midline surgical scar is visible.The knee appears enlarged compared to the surrounding limb.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a healthcare professional.They state that a total knee arthroplasty was performed using unknown products.One year later, a revision surgery was performed, and a cemented nexgen lcck system was implanted due to flexion instability.Following the revision, the patient initially reported significant improvement in stability and mobility, was discharged full weight-bearing, and used a rolling walker during the early post-operative period.However, over the following months, symptoms gradually returned, including swelling, pain, stiffness, instability, and a cracking or popping sensation.The patient also experienced an itchy rash described as though clinical assessment did not support an allergic reaction.The knee was noted to be warm to the touch, and mild effusion and inflammation were observed.The patient was later released for light duty.Serial assessments showed a progressive decline in range of motion, from 0¿130 initially to 0¿90.Six (6) years post-op, symptoms had worsened and included ongoing swelling, pain, stiffness, instability, buckling, redness, difficulty walking, and a cracking sound or loud painful pops.An mri showed no signs of loosening.All implants remain in place, and the patient is requesting a recall check.These persistent symptoms more than six months post-operatively are considered a serious injury.Root cause was unable to be determined.Reported event was confirmed by review of provided medical records.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 at time of this report.

• Brand Name: NEXGEN SIZE 5 PRECOAT CEMENTED STEMMED ANTERIOR/POSTERIOR TIBIAL COMPONENT
• 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: 21632070
• Report Number: 0001822565-2025-00648
• Device Sequence Number: 18026418
• Product Code: JWH
• UDI-Device Identifier: 00889024220454
• UDI-Public: (01)00889024220454(17)261231(10)63548576
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00598800500
• Device Lot Number: 63548576
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 88 KG