MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling (2091); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671); No Information (3190)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Customer has not indicated whether or not the product will 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 two and half years post implantation due to implant fracture.The patient presented a secondary rupture of the patellar tendon, possibly traumatic.There is no additional information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated report: 0001822565-2019-05071.Concomitant medical products: articular surface with hinge post size e 12 mm height item# 00588005012 lot# 63516115, stem extension straight 15mm dia x 100mm length item# 00598801015 lot# 63464365.The product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information and correct previously submitted information.
Event or Problem Description
It was reported that a patient was revised approximately two and half years post implantation due to implant fracture.Patient experienced left knee pain and difficulty ambulating.Left knee revision performed, noted the hinge had fractured and fragment had migrated, along with poly fracture.Patient had tendon tear repaired with anchors.There is no additional information at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.H3- customer has indicated that the product will 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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the returned product identified fracture hinge and bone cement is adhering to the femur.Articular surface is damaged in the anterior side.Fractured hinge was submitted for further analysis.Analysis determined that bending overload caused the fracture.The crack was suspected to be initiated near the inner diameter and propagated towards the outer diameter of the hinge.Fractured surface appear to be excessive smeared edges and biological debris.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: no complication was noted during both initial and revision surgery.The patient presented with patella tendon rupture along with pain, infra-articular serous effusion.Ct scan noted hinge fracture and metal fragments were migrated.Large amount of poly debris reaction along the anteromedial area was noted and poly was fractured along the anterior side.Scar tissues were noted.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.Per package insert 87-6203-904-23 rev c, nexgen rotating hinge knee: fracture, pain, swelling, wear is known adverse effect of this system.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: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9176594
• Report Number: 0001822565-2019-04360
• Device Sequence Number: 17114872
• Product Code: KRO
• UDI-Device Identifier: 00889024199149
• UDI-Public: (01)00889024199149
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/01/2020

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: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00588001501
• Device Lot Number: 63384340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/16/2019; 10/16/2019; 11/13/2019; 03/30/2020
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 10/22/2019; 11/06/2019; 11/26/2019; 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 120