MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT HIGH FLEX PRECOAT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Arthritis (1723); Metal Related Pathology (4530)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10-medical product: tibial component precoat right medial/left lateral size 3 item# 00584200302 lot# 63754112.Unknown zuk bearing.G2- australia visual examination of the provided pictures identified product that had been implanted.The articular surface looks worn, and the tibial plate and femoral implant have biological material on them.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fit and alignment appropriate, no evidence of metallosis, wear on bearing.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.This complaint for implant wear is confirmed via provided photos, however metallosis could not be confirmed.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H6: component code: proposed component (annex g) code is: - mechanical (04) - femur.
Event or Problem Description
It was reported that a patient was revised due to metallosis.On revision, the medial compartment was felt to be over-stuffed and with inadequate tibial slope.The patient had been dropping off the back of the tibial component and eroded the poly.Some metallosis was discovered.The implants were otherwise well fixed.There is no additional information available.

• Brand Name: FEMORAL COMPONENT HIGH FLEX PRECOAT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19073733
• Report Number: 0001822565-2024-01191
• Device Sequence Number: 6853377
• Product Code: HSX
• UDI-Device Identifier: 00889024193758
• UDI-Public: (01)00889024193758(17)280229(10)63943904
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 04/09/2024

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: 00584201302
• Device Lot Number: 63943904
• 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: 03/27/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2018
• 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: Male
• Patient Weight: 80 KG