MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL FEMORAL COMPONENT FOR CEMENTED USE ONLY IN THE USA SIZE C LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Fever (1858); Rash (2033); Staphylococcus Aureus (2058); Swelling (2091); Discharge (2225); Ambulation Difficulties (2544)

Event Date 02/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of medical records and analysis of returned device.The poly components showed minimal signs of wear.Measured dimensions were conforming to print specification.Device history record (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.Concomitant medical products - stem collar 35 mm o.D., catalog #: 00585204035 lot #: 63284526, tibial block and screws precoat size 2 5 mm thickness, catalog #: 00598800226 lot #: 63168114, stem extension straight 11mm dia x 100mm length, catalog #: 00598801011 lot #: 63451500, palacos r+g 1x40, catalog #: 66022663 lot #: 86604591, fluted stem extension straight precoat, catalog #: 00585205011 lot #: 63574485, tibial component precoat size 2, catalog #: 00588000200 lot #: 63696269, tibial block and screws precoat size 2.5 mm, catalog #: 00598800226 lot #: 63281479, articular surface with segmental hinge post size c 14 mm height, catalog # 00585003014, lot # 62788895, polyethylene insert size c, catalog # 00585001395, lot # 63649607.Multiple reports have been submitted for this event.Please see associated reports: 0001822565 - 2018 - 01479, 0001822565 - 2018 - 01480, 0001822565 - 2019 - 00964, 0001822565 - 2019 - 00965.

Event Description

It was reported that the patient presented with swelling, discharge, fever and had reported recent falls.The patient was then revised to address an infection.It was further reported through patient's medical records that the patient was noted to have pji and haemarthrosis which was likely haematologically seeded.Patient also reported to have itchy macular rash.Furthermore, the pus culture was (b)(6) and therefore, the patient was started on antibiotics.Finally, it was noted the patient is using a cane to ambulate.Attempts have been made and no further information has been provided.

• Brand Name: DISTAL FEMORAL COMPONENT FOR CEMENTED USE ONLY IN THE USA SIZE C 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: 8380338
• MDR Text Key: 137502751
• Report Number: 0001822565-2019-00964
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00585001301
• Device Lot Number: 63588147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention