MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CRUCIATE RETAINING CR-FLEX FEMORAL COMPONENT POROUS UNCEMENTED; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Medical device site infection (4845); Aseptic loosening (4883)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00598004702, tibial component, unknown lot.00595204014, articular surface, unknown lot.G2: foreign - event occurred in australia.H6: proposed component code: mechanical (g04) - femur.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported a patient underwent an initial knee surgery on an unknown date.Subsequently, the patient presented infection and loosening of tibial and femoral components leading to a revision surgery.The surgeon removed all components and replaced them with a spacer.No further information has been provided.
Additional Manufacturer Narrative
D10: 00595204014, articular surface, 64458786.00598004702, tibial component, j6496165.00597206532, all poly patella, 65270033.No devices were received.Photograph provided shows explanted implants with blood stains and a detailed evaluation could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.No medical records were provided.Root cause cannot be determined for loosening.It was determined that the reported infection has a root cause unrelated to the implanted zimmer biomet device.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
It was reported a patient underwent an initial knee surgery.Subsequently, the patient presented infection and loosening of tibial and femoral components leading to a revision surgery approximately 3 years later.The surgeon removed all components and replaced them with a spacer.No further information has been provided.

• Brand Name: CRUCIATE RETAINING CR-FLEX FEMORAL COMPONENT POROUS UNCEMENTED
• 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: 23705368
• Report Number: 0001822565-2025-04377
• Device Sequence Number: 16100865
• Product Code: JWH
• UDI-Device Identifier: 00889024259614
• UDI-Public: (01)00889024259614(17)280831(10)64052009
• 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: 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,Followup
• Report Date (Section B): 03/10/2026

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: 65595201502
• Device Lot Number: 64052009
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Unknown