MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Hyperextension (4523); Swelling/ Edema (4577)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient is experiencing pain and hyperextension in knee post implantation.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: nexgen femoral component, catalog # 00599601602, lot # 64742814.Stemmed nonaugmentable tibial component, catalog # 00598604701, lot # j6720198.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 it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2024-00071 h3 other text : device remains implanted.
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.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.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.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.
Event or Problem Description
It was reported patient underwent a revision procedure three years post implantation due to pain and hyperextension in knee.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Updated: b2, b3, b5, b4, b5, d2, d6b, e1, g1, g3, g6, h1, h2, h6.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Updated: b4, b5, b7, d2, e1, g1, g3, g6, h1, h2, h6.
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
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Updated: b4, b5, d2, e1, g1, g3, g6, h1, h2.
Event or Problem Description
No further event information available at the time of this report.
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, h10, h11.H6: device not accessible for testing is n/a which was reported on initial report.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.Additional information does not affect the root cause.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 ARTICULAR SURFACE
• 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: 18888076
• Report Number: 0001822565-2024-00884
• Device Sequence Number: 3038053
• Product Code: JWH
• UDI-Device Identifier: 00889024211957
• UDI-Public: (01)00889024211957(17)271031(10)64556180
• 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,Followup,Followup,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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00596404012
• Device Lot Number: 64556180
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 08/06/2024; 10/11/2024; 11/25/2024; 03/10/2025; 04/28/2025
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 08/13/2024; 10/29/2024; 12/16/2024; 03/26/2025; 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 79 KG