MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMORAL COMPONENT PRECOAT SIZE F LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised four years, six months post implantation due to age related soft tissue laxity.Invoices show all components were replaced.No additional information available.
Additional Manufacturer Narrative
(b)(4).G2:australia.H6-component code- suggested code: mechanical (g04) - femur.No devices or photographs were returned back for investigation.Review of the device history records identified no related deviations or anomalies during manufacturing.The articular surface was not compatible with the femoral implant used.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.X-ray review by third party hcp states that there is asymmetric lateral compartment narrowing with suspected polyethylene wear as noted.The reported event states that it is age related soft tissue laxity and also it was found that incompatible femoral and articular surface combination was used; however, it is not clear what caused the reported event hence a root cause cannot be determined.Instruction for use, under warnings shows articular surface was not compatible with the femoral implant used.This complaint cannot be confirmed.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Additional associated products: 00597604010, nexgen articular surface anterior constrained, size 10mm,lot# 64369684.

• Brand Name: FEMORAL COMPONENT PRECOAT SIZE F LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20749822
• Report Number: 3007963827-2024-00467
• Device Sequence Number: 15544222
• Product Code: JWH
• UDI-Device Identifier: 00889024191235
• UDI-Public: (01)00889024191235(17)281130(10)64128076
• 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: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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 Model Number: N/A
• Device Catalogue Number: 00575001601
• Device Lot Number: 64128076
• 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: 11/20/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 62 KG