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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthritis (1723)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10-medical product articular surface size ef 12 mm height item# 00596404012 lot# 63093737 stemmed nonaugmentable tibial component option cr/ps/lps size 5 item# 00598604701 lot# 63472937 bone cement item# 3095040 lot# 8474668 g2- united kingdom h3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient was revised approximately seven years post implantation due to unknown reasons.There is no additional information available.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h4, h6, and h11.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.The reported event is not confirmed.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch will be filed accordingly.Zimmer biomet will continue to monitor for trends.H6: component code: proposed component (annex g) code is: - mechanical (g04) - femur.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Upon reassessment of the information, it was determined that this item was reported in error.There are no allegations against the femoral component as the reported issue is for tibial loosening and articular surface wear.Please void previous report regarding the femoral component.
Event or Problem Description
Upon reassessment of the information, it was determined that this item was reported in error.There are no allegations against the femoral component as the reported issue is for tibial loosening and articular surface wear.Please void previous report regarding the femoral component.

• Brand Name: FEMORAL COMPONENT OPTION SIZE F RIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• 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: 20043187
• Report Number: 3007963827-2024-00318
• Device Sequence Number: 7955095
• Product Code: JWH
• UDI-Device Identifier: 00889024001145
• UDI-Public: (01)00889024001145(17)270228(10)63605137
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• 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,Followup,Followup
• Report Date (Section B): 08/06/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00596401652
• Device Lot Number: 63605137
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 01/31/2025; 07/21/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 02/04/2025; 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2017
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown