MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN ALL POLY PETELLA STANDARD CEMENTED SIZE 35 MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Malposition of Device (2616); Naturally Worn (2988); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 : 00588001601 - left size f cemented option femoral component femoral plastic cap must be removed prior to implantation - 63932973.00598801215 - 15mm diameter 30mm length straight stem extension combined length 75mm - 64732973.00588000500 - size 5 precoat cemented tibial component - 63847192.00598801015 - 15mm diameter 100mm length straight stem extension combined length 145mm - 64280968.00588006012 - 12mm height size f articular surface with hinge post extension / use with plate 5,6 / screw enclosed do not discard - 64174108.66022663 - palacos r + g (1x40) - 90614738.66022663 - palacos r + g (1x40) - 96124845.G2 : foreign country : australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial left total knee arthroplasty.Approximately 3.5 years later, they underwent a revision of the patella for noise, malalignment, and scar tissue.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was further reported that the surgeon noted wear on the implant and that the patient was experiencing discomfort.This discomfort was described as pain.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided photograph shows wear consistent with wear.Device was not returned back for evaluation.The device history record was reviewed and no discrepancies relevant to the reported event were found.Primary surgery records state that there were no intra operative complications.X-rays were provided and reviewed by a third-party health care professional and state that left total knee arthroplasty with possible polyethylene wear and/or malalignment of the patella component.A definitive root cause cannot 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN ALL POLY PETELLA STANDARD CEMENTED SIZE 35 MM
• 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: 19172895
• Report Number: 0002648920-2024-00117
• Device Sequence Number: 7817746
• Product Code: JWH
• UDI-Device Identifier: 00889024635395
• UDI-Public: (01)00889024635395(17)280229(10)64620677
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2024

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: 00597206535
• Device Lot Number: 64620677
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 05/05/2024; 09/20/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/13/2024; 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 71 KG