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

Catalog Number	00597206532
Medical Device Problem Codes	Material Erosion (1214); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient underwent a knee revision approximately 3 years 8 months post implantation due to infection.During the revision, wear and cracking of the patella was noted.The articular surface and patella were exchanged with unknown product.
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; h11.Visual examination of the provided photos identified the explanted patella with remnants of patient tissue on its surface.The patella appears to have cracks along the edges.No further evaluation can be performed based on the images provided.The device history record was reviewed and no discrepancies relevant 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 revision of the left total knee replacement due to instability and poor ingrowth of the cementless components.The procedure involved replacing the existing implant with a zimmer biomet rotating hinge knee (zb rhk) system and utilizing autografts for both the tibial and femoral components.Intraoperative findings included a markedly internally rotated tibial tray and patellar maltracking, which contributed to lateral wear and cracking of the patellar component.These issues were addressed during the revision surgery, resulting in stable range of motion and improved patellar tracking postoperatively.Additionally, a separate procedure involving washout and polyethylene exchange was performed to address a suspected infection following the patient's travel to bali and a urinary tract infection; during this procedure, the worn and cracked patellar component was also revised.For the wear and crack issues: a definitive root cause cannot be determined.For the infection issue: the root cause of the infection was determined to be unrelated to the implanted zimmer biomet devices.This complaint cannot be confirmed for the infection issue while it can be confirmed for the wear and crack issue on the patella based on the medical records and photos provided.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 32 MM DIAMETER 8.5 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: 21197989
• Report Number: 0002648920-2025-00015
• Device Sequence Number: 12847433
• Product Code: JWH
• UDI-Device Identifier: 00889024215146
• UDI-Public: (01)00889024215146(17)280721(10)64774898
• 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: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00597206532
• Device Lot Number: 64774898
• 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: 01/03/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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: Female