MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STANDARD CEMENTED ALL POLY PATELLA SIZE 32MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - nexgen stemmed nonaugmentable option tibial component size 3 catalog #: 00598603701 lot #: 63535337, nexgen lps-flex articular surface size cd 12mm catalog #: 00596403012 lot #: 63631119, nexgen option cemented femoral component size d right catalog #: 00576401452 lot #: 63342343 g2 - report source - foreign: the event occurred in the united kingdom.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 developed deep vein thrombosis four (4) days following an initial right knee arthroplasty.The patient was placed on anticoagulants.No additional information is available.
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 device history records were not reviewed as the reported event was determined to be unrelated to the implanted device.Procedure-related complications are influenced by the type of surgery, a patient's pre-existing comorbidities, and perioperative management.Deep vein thrombosis (blood clot), or dvt, occurs when a blood clot forms in one of the deep veins of the body.This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops.Total joint patients are typically placed on medication post-operatively to prevent dvt formation.Even with the administration of preventive medication, dvts can still develop.As the complaint indicated, a post-operative complication occurred, and medical intervention was required for treatment.The root cause of the reported event was determined to be traced to non-device related factors.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
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, g3, g6, h2, h6, h11.Additional records received were reviewed, however, the root cause remains not device-related, as the reported event is procedure-related.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN STANDARD CEMENTED ALL POLY PATELLA SIZE 32MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20070867
• Report Number: 0002648920-2024-00276
• Device Sequence Number: 20779350
• Product Code: JWH
• UDI-Device Identifier: 00889024635388
• UDI-Public: (01)00889024635388(17)240630(10)63409706
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K933785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/17/2025

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: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00597206532
• Device Lot Number: 63409706
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 12/06/2024; 03/19/2025; 06/03/2025
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 12/23/2024; 04/14/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2016
• 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
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White