MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ROTATING HINGE KNEE LEFT SIZE D CEMENTED OPTION FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a rotating hinge knee procedure.Subsequently, approximately thirty (30) months post-implantation, the patient was revised due to femoral loosening.No further information has been provided. .
Additional Manufacturer Narrative
(b)(4).D10 medical devices: rotating hinge knee tm femoral diaphyseal cone 30mm, catalog#: 00545001830, lot#: 63770738.Rotating hinge knee femoral augment block size d 20 mm, catalog#: 00599003424, lot#: 64103993.Rotating hinge knee femoral augment block precoat size d 20 mm, catalog#: 00599003424, lot#: 77003570.Unknown tibial insert catalog#: ni lot#: ni.13mm diameter 100mm length straight stem extension combined length 145mm catalog#: 00598801013, lot#: 65027757.Palacos r + g (1x40) catalog#: 66022663, lot#: 98091024.Unknown tibial tray catalog#: ni lot#: ni.G2 foreign source: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates that the patient underwent a revision of the femoral rhk components.The previous surgery was a second-stage revision, where a rotating hinge knee (rhk) was implanted.The patient¿s history includes multiple prior interventions, including a poly exchange, vastus lateralis free flap, extensor tendon reconstruction, and washout post-free flap reconstruction.During the revision, the rhk femoral component, femoral augment blocks, trabecular metal femoral diaphyseal cone, and palacos cement were explanted.A new rhk femoral component and simplex cement were implanted.The tibial components and stem extension were retained.X-ray review indicates that minimal radiolucency is observed along the femoral stem.No fracture is identified.The impressions indicate that the radiolucency is nonspecific but could suggest early loosening.The fit and alignment of the implants are deemed appropriate, and mild osteopenia is noted.No other anatomical or implant concerns that would lead to revision were identified.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ROTATING HINGE KNEE LEFT SIZE D CEMENTED OPTION FEMORAL COMPONENT
• 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: 20733480
• Report Number: 0001822565-2024-03638
• Device Sequence Number: 8304832
• Product Code: JWH
• UDI-Device Identifier: 00889024199125
• UDI-Public: (01)00889024199125(17)250331(10)64549912
• 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
• 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
• Report Date (Section B): 02/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00588001401
• Device Lot Number: 64549912
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 106 KG