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

Model Number	5972-65-32
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty on an unknown date.Approximately two years post implantation, the patient presented with a clunk in the patella and anterior knee pain.Subsequently, the patient underwent revision surgery of the patella component.Due diligence is complete and all available information has been provided for this event.
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: femoral component option for cemented use only size e left: catalog#00576401551, lot#63813614; articular surface size ef 10 mm height: unknown, catalog#00596203210, lot#64690182; stemmed tibial component precoat size 3: catalog#00598003701, lot#j6716382.Report source: foreign: australia.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.The condition of the component is unknown.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to 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.

• Brand Name: 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: 16611134
• Report Number: 0002648920-2023-00038
• Device Sequence Number: 14685393
• Product Code: JWH
• UDI-Device Identifier: 00889024215146
• UDI-Public: (01)00889024215146(17)270430(10)64398655
• 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: 2022
• 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
• Report Date (Section B): 03/22/2023

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: 5972-65-32
• Device Catalogue Number: 00597206532
• Device Lot Number: 64398655
• 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: 02/28/2023
• Initial Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female