MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ALL POLY PETELLA STANDARD CEMENTED SIZE 32 MM DIAMETER 8.5 MM THICKNESS; PROSTHESIS, KNEE

Catalog Number	00597206532
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Synovitis (2094); Subclinical Infection (2247); Impaired Healing (2378); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: unknown nexgen femur size d: catalog# ni, lot# ni; unknown nexgen tibia size 2: catalog# ni, lot# ni; unknown nexgen poly 10mm: catalog# ni, lot# ni; unknown cement: catalog# ni, lot# ni.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-03641, 0001822565-2021-03642, 0001822565-2021-03643.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 a patient underwent an initial right total knee arthroplasty.Approximately three months post implantation, the patient underwent a manipulation under anesthesia due to pain, swelling, difficulty ambulating and limited range of motion.In spite of the intervention, the patient continued to experience the same and increased symptoms.Additionally, the patient experienced continuous warmth and redness to the site which was resistant to ice, elevation, and antibiotic therapy.All cultures and bloodwork were negative for infection.Approximately one year and nine months post initial implantation, the patient was revised of all components with implantation of an antibiotic spacer with intra-op frozen section specimens concerning for infection.Attempts have been made and no further information was provided.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were provided and reviewed by a health care professional.Review found that three weeks post implantation, patient slipped in the bathroom and hurt her knee.Three months post implantation patient underwent mua due to arthrofibrosis.Patient continues to have pain, swelling, bruising, and uses a walker/cane, clicking/popping, burning sensation.X-ray review found no complications.Manipulation did not improve conditions.Patient was revised due to concerns for infection however they were unable to grow any bacteria from sonication.Root cause was unable to 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d1; d3; d4; d10; g3; g4; h4; h11.D10: medical product: nexgen femoral component size d right: catalog#00599601452, lot#63958116; nexgen stemmed tibial component precoat size 2: catalog#00598002702, lot#64005821; nexgen articular surface size cd 10mm height: catalog#00596402210, lot#63769606.Additional information provided has prompted a review of the previously reported investigation results.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.Approximately three months post implantation, the patient underwent a manipulation under anesthesia due to pain, swelling, difficulty ambulating and limited range of motion.In spite of the intervention, the patient continued to experience the same and increased symptoms.Additionally, the patient experienced continuous warmth and redness to the site which was resistant to ice, elevation, and antibiotic therapy.All cultures and bloodwork were negative for infection.Approximately one year and nine months post initial implantation, the patient was revised of all components with implantation of an antibiotic spacer.A competitor knee system was later implanted.It was further reported that the patient has continued to experience complications from the implanted joint.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g2; g3; h2; h10; h11.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review found that three weeks post implantation, patient slipped in the bathroom and hurt her knee.Three months post implantation patient underwent mua due to arthrofibrosis.Patient continues to have pain, swelling, bruising, and uses a walker/cane, clicking/popping, burning sensation.X-ray review found no complications.Manipulation did not improve conditions.Patient was revised due to concerns for infection however they were unable to grow any bacteria from sonication.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 ALL POLY PETELLA STANDARD CEMENTED SIZE 32 MM DIAMETER 8.5 MM THICKNESS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13061372
• Report Number: 0001822565-2021-03644
• Device Sequence Number: 19871929
• Product Code: JWH
• UDI-Device Identifier: 00889024215146
• UDI-Public: (01)00889024215146(17)250930(10)63785086
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/28/2025

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: 09/30/2025
• Device Catalogue Number: 00597206532
• Device Lot Number: 63785086
• 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: 12/03/2021
• Supplement Date Received by Manufacturer: 02/02/2022; 11/11/2024; 12/06/2024; 04/28/2025
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/07/2022; 12/10/2024; 01/03/2025; 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2017
• 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 H10 NARRATIVE.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Race: White