MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Ossification (1428); Unspecified Infection (1930); Local Reaction (2035); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 01/12/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: unknown item # - bearing - 823990; 141224 - tibial tray - 370960.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00250, 0001825034-2022-00252.

Event Description

It was reported that the patient underwent a knee revision approximately 17 years post implantation due to poly wear and metallosis.It was noted that the knee was infected.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: component code - mechanical (g04) - femur no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.The root cause for infection per nursing review was found to be non-device related.A definitive root cause cannot be determined for metallosis, pain and wear.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN FEMORAL COMPONENT
• 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: 13417224
• MDR Text Key: 284857969
• Report Number: 0001825034-2022-00251
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• 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: UNKNOWN
• Device Lot Number: 226960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male