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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 06/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: trabecular metal tibial cone, medium 31x31mm, catalog #: 00545001331, lot #: 64700231; tibial component precoat size 2, catalog #: 00588000200, lot #: 64146578; stem extension straight 12.7 mm dia.X 30 mm length (combined length 75 mm), catalog #: 00598801212, lot #: 62762283; trabecular metal femoral metaphyseal cone, 35mm, small, left, catalog #: 00545002035, lot #: 64249422; stem extension straight long 14mm dia x 155mm length(combined length 200mm), catalog #: 00598801114, lot #: 63240767; prc agmt block dist sz e 10mm, catalog #: 00-5990-035-20, lot #: 62708077; prc agmt block dist sz e 10mm, catalog #: 00-5990-035-20, lot #: 63789533; prc agmt block dist sz e 5mm, catalog #: 00-5990-035-01, lot #: 63832525; prc agmt block dist sz e 5mm, catalog #: 00-5990-035-01, lot #: 64630746; the complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested from hospital and not returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Reference report: 0001822565 - 2021 - 01942, 0001822565 - 2021 - 01943.Investigation incomplete.

Event Description

It was reported a patient was revised due to hinge post was dislocated from rotating hinge knee femoral hinge and articular surface was dislocated from tibial component.Attempts have been made, but there is no additional information at this time.

Manufacturer Narrative

The results of the investigation are as follows: -no product was returned or pictures provided; visual and dimensional evaluations could not be performed.-review of the device history record(s) identified no deviations or anomalies during manufacturing.-a definitive root cause cannot 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.

Event Description

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

• Brand Name: NEXGEN FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E LEFT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12196293
• MDR Text Key: 262443139
• Report Number: 0001822565-2021-01965
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024199149
• UDI-Public: (01)00889024199149(17)240831(10)64366815
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

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 Model Number: N/A
• Device Catalogue Number: 00588001501
• Device Lot Number: 64366815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 11/23/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female