MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT; PROSTHESIS KNEE

Catalog Number	00598604701
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Swelling/ Edema (4577)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure three years post implantation due to pain, swelling, hypertension and instability in knee.All implants, except the patella, were revised without complication.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: nexgen femoral component catalog # 00599601602 lot # 64742814.Nexgen articular surface catalog # 00596404012 lot # 64556180.All poly petella catalog # 00597206535 lot # 64325356.Palacos r+g catalog # 66017569 lot # 94774924.G2: united kingdom.H3: customer has indicated that the product will not be returned because 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
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, d9, g3, g6, h1, h2, h3, h6, h11.Reported event was confirmed by review of medical records provided.Visual evaluation of the returned device shows signs of repeated use and implantation as the devices have surface scratches, nicks, gouges, and pitting on the articular surface.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Additionally, the cause of the patient falls are unknown.Medical records review indicates that er noted pain/swelling/erythema, leg is swelling, no calf tenderness; most pain is coming from spine; us guided injection to right hip; right tka- cruciate sacrificing ¿ experiencing hyperextension; revision dx: instability.X-ray review indicates there is anatomic alignment of the right knee arthroplasty without overall change.Implant fit and alignment are maintained.Bone quality is mildly osteopenic.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.

• Brand Name: NEXGEN STEMMED NONAUGMENTABLE 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: 21917477
• Report Number: 0001822565-2025-01166
• Device Sequence Number: 9022495
• Product Code: JWH
• UDI-Device Identifier: 00889024218857
• UDI-Public: (01)00889024218857(17)300108(10)J6720198
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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
• Device Catalogue Number: 00598604701
• Device Lot Number: J6720198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2020
• 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 Sex: Male
• Patient Weight: 79 KG