MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN ALL POLY PETELLA STANDARD CEMENTED SIZE 32 MM DIAMETER 8.5 MM THICKNESS; PROSTHESIS, KNEE

Catalog Number	00597206532
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Tactile Disorders (4419); Paresthesia (4421); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: patello-femoral trochlea component precoat for cemented use only size 2, left: catalog#00592601201, lot#65246095; unknown cement: catalog#ni, lot#ni.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported via a clinical study that a patient had an initial left patellofemoral joint arthroplasty.Subsequently, six (6) weeks post-operation, the patient was diagnosed with saphenous nerve dysesthesia for nerve pain/paresthesia and was prescribed additional medication.The patient continued to have intermittent flares of pain and experienced an exacerbation of pain and swelling eight months post-implantation following a bike ride and underwent an aspiration and corticosteroid injection.Three (3) months following the injection, the patient was still experiencing worsening saphenous nerve dysesthesia and peripheral nerve block.Additional pain medication was prescribed all diagnostic images showed satisfactory position of the implants and the patient completed participation in the clinical study.All available information has been reported.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a left patellofemoral joint arthroplasty.One month post-surgery, she was diagnosed with saphenous nerve dysesthesia, resulting in nerve pain and paresthesia, for which she was prescribed lyrica.She continued to experience intermittent flares of pain and had an exacerbation of pain and swelling following a bike ride.An aspiration and injection of triamcinolone acetonide were performed.Subsequently, the patient visited the doctor due to worsening saphenous nerve dysesthesia over the previous two weeks.The doctor attributed the condition to a peripheral nerve block administered during surgery.Radiographic imaging showed that the implants were in a satisfactory position, and the patient was considered study complete with no further issues.Root cause was unable to be determined.Reported event was confirmed by review of provided medical records.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.

• Brand Name: NEXGEN ALL POLY PETELLA STANDARD CEMENTED SIZE 32 MM DIAMETER 8.5 MM THICKNESS
• 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: 19299081
• Report Number: 0002648920-2024-00139
• Device Sequence Number: 6980571
• Product Code: JWH
• UDI-Device Identifier: 00889024635388
• UDI-Public: (01)00889024635388(17)271130(10)65661070
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 00597206532
• Device Lot Number: 65661070
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 52 KG
• Patient Race: White