MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLYETHYLENE INSERT XT SIZE B USE WITH DISTAL FEMORAL XT SIZE B USE WITH XT ONLY; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 00585002012, articular surface with segmental hinge post, lot # 63544508, 00585004201, distal femoral xt component, lot # 63876621, 00588000300, tibial component, lot # 63847191.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00241, 0001822565 - 2020 - 00242, 0001822565 - 2020 - 00243.
Event or Problem Description
It was reported that approximately 18 months post implantation, the patient experienced a fall and suffered pain and instability.Upon x-ray imaging, it was identified that the yoke had fractured.Subsequently, the patient was revised and all fractured components were exchanged.During the revision, there was fluid noted in the knee joint and damage noted to the poly bearing.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d10, g4, g7, h1, h2, h3, h6, h10 d4: udi # (b)(4).The complaint is confirmed.Visual evaluation of the returned implant confirmed fractured hinge post.Device was submitted for further analysis.Analysis determined that the fatigue caused the fracture.Multiple crack initiation sites were seen in the inner and outer edge of the fracture sample.Material analysis was conforming to the print specification.Also, the femur, articular surface, and poly box were returned.All these components show signs of use.The poly box was also damaged/fractured.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fractured yoke component displaced in the anterolateral knee joint recess.Periprosthetic lucency at the interface of the distal femoral bone and the tibial component is noted, age indeterminate, and clinical significance indeterminate.Also, overall fit and alignment as well as bone quality appear normal.A definitive root cause cannot be determined.Per package insert: fracture, pain, instability are known adverse effects 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: POLYETHYLENE INSERT XT SIZE B USE WITH DISTAL FEMORAL XT SIZE B USE WITH XT ONLY
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9616029
• Report Number: 0001822565-2020-00244
• Device Sequence Number: 16828992
• Product Code: KRO
• UDI-Device Identifier: 00889024195639
• UDI-Public: (01)00889024195639
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00585001296
• Device Lot Number: 63751247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 117