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

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: femoral component option for cemented use only size d right, catalog #: 00576401452, lot #: 64183847.Nexgen all poly patella, catalog #: 00597206529, lot #: 64445099.Stemmed tibial component precoat size 2 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem extender, catalog #: 00598002702, lot #: 64422997.Report source: (b)(6).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: 0002648920-2021-00115.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient had severe pain.The patient had physiotherapy and the pain was reduced but not eliminated.Constantly taking x-rays, it was found that one of the problems that arose from this surgery was the erosion and inhomogeneity of the implantable patella.Attempt for further information has been made, but no further information has been provided.From additional information received, it was reported that that x-rays shows normal position of the implants but irregularity of the patella and wear of the articular surface.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10 reported event was confirmed by review of medical records provided.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.The contact was sent the investigation results.Medical records and x-ray review indicates irregularity of the patella with an image of articular surface wear; the prosthesis and osteosynthesis material are located in normal position.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
No further event information available at the time of this report.

• Brand Name: NEXGEN ARTICULAR SURFACE
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11836232
• Report Number: 0001822565-2021-01363
• Device Sequence Number: 1061202
• Product Code: JWH
• UDI-Device Identifier: 00889024211704
• UDI-Public: (01)00889024211704(17)270531(10)64404628
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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 Model Number: N/A
• Device Catalogue Number: 00596402210
• Device Lot Number: 64404628
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention