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

Model Number N/A

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Dob: (b)(6).(b)(4).Concomitant medical products: unknown cup, unknown liner, unknown head.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to location of device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient¿s hip was revised due to implant fracture after experiencing distortion trauma while climbing the stairs.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Reported event was confirmed by review of medical records and radiographs received.Medical records were provided and reviewed by a health care professional.Review of the available records identified the patient has a history of stroke with hemiparesis leads to difficulty ambulating and distorted gait/movement control.The patient was climbing stairs using a twisting motion, putting torsional stress on the implant.The lower leg was hanging to the outside.Since then, the patient had increasing discomfort in the area of the left knee joint, within increasing effusion and radiological evidence of implant failure.Review of the available radiographs identified anatomic alignment of the left knee arthroplasty components with a long-stem tibial implant traversing an oblique tibial fracture.Visual examination of the provided pictures identified a fracture of the rotating knee hinge.Visual examination of the provided photos pf the device identified a fracture of the rotating knee hinge.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported patient underwent initial left total knee arthroplasty on an unknown date.Subsequently, the patient was revised after the patient experienced torsional trauma to the left leg while climbing the stairs resulting in increased pain and swelling in the knee.During the revision, a fracture of the axle mount was confirmed as well as deep scratches to the poly.The revision of damaged components occurred without complication.

• Brand Name: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F LEFT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8804993
• MDR Text Key: 151549196
• Report Number: 0001822565-2019-03095
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: 5
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/13/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00588001601
• Device Lot Number: 63417074
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 07/24/2019; 07/24/2019; 10/24/2019
• Supplement Dates FDA Received: 07/26/2019; 08/19/2019; 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 133