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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Alteration In Body Temperature (2682)

Event Date 08/08/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Concomitant medical products: kne-persona-bearings-unk; p/n: unk, l/n: unk.Kne-persona-femorals-unk; p/n: unk, l/n: unk.Kne-persona-tibial trays-unk; p/n: unk, l/n: unk.Kne-persona-patellas-unk; p/n: unk, l/n: unk.Kne-persona-stems-unkt; p/n: unk, l/n: unk.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04052, 0001822565 - 2019 - 04053, 0001822565 - 2019 - 04055.Remains implanted.

Event Description

It was reported the patient is experiencing pain, swelling, knee getting cold plus hot continually and inflammation after initial surgery.Subsequently, a revision is scheduled for a later time.However, no revision procedure has been reported to date.No further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.D11 - concomitant medical products - patella, item #: unknown lot #: 87524706g17.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: UNKNOWN PERSONA FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9092323
• MDR Text Key: 161835216
• Report Number: 0001822565-2019-04053
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other