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

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a right knee arthroplasty, a left femoral component was implanted.Reportedly, the hospital had other similar procedures planned for that week and it was not realized prior to the procedure by inventory control or by medical staff during the procedure that there was a left-oriented femoral component placed in the operating room, which had been intended for another procedure.The error was discovered after the left-oriented femoral component had been implanted in the patient's right knee.Since the procedure, the patient has not experienced any pain and has good knee extension and flexion.The patient was scheduled for a revision surgery to replace the femoral component with a right-oriented implant; however, the procedure was cancelled, as the patient was doing well post-operatively and the surgeon deemed the revision unnecessary.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - nexgen rotating hinge knee articular surface with hinge post size d 12mm catalog #: 00588004012 lot #: 66701267, nexgen rotating hinge knee precoat cemented tibial component size 4 catalog #: 00588000400 lot #: 64716349, nexgen standard cemented all poly patella 32mm catalog #: 00597206532 lot #: 66466985, nexgen straight stem extension 11mm x 100mm catalog #: 00598801011 lot #: 66455915.G2 - report source - foreign: event occurred in france.The complainant has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted.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 submitted to relay additional and corrected information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The following sections were corrected: h4.H6 - component code - proposed code is mechanical (g04) - femur.The product was evaluated through manufacturing review; however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.The instructions for use state to not use the product for other than labelled indications as the risk of implant failure is higher with inaccurate component alignment or positioning.Appropriate device selection is crucial to obtain a proper fit.The root cause can be attributed to off-label use, as the wrong femoral component was implanted in accordance with the instructions for use.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a4, b4, b7, g3, g6, h2, h11.

• Brand Name: NEXGEN ROTATING HINGE KNEE CEMENTED OPTION FEMORAL COMPONENT LEFT SIZE D
• 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: 20894449
• Report Number: 0001822565-2024-03897
• Device Sequence Number: 15686898
• Product Code: KRO
• UDI-Device Identifier: 00889024199125
• UDI-Public: (01)00889024199125(17)290717(10)65978145
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 10/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00588001401
• Device Lot Number: 65978145
• 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: 11/28/2024
• Supplement Date Received by Manufacturer: 04/14/2025; 09/17/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 04/18/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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.
• Patient Sex: Male
• Patient Weight: 82 KG