MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN FINN STEM; PROSTHESIS KNEE

Model Number N/A

Device Problems Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date - (b)(6) 2016.Concomitant medical products - unknown regenerex tibial tray, unknown biomet femur, unknown biomet bearing.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-11362 and 0001825034-2017-11364.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.

Event Description

It was reported that the patient underwent a revision surgery approximately 20 months post initial surgery due to pain.The surgeon noticed metallosis and a hairline fracture of tibial component during surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.Complaint history review was unable to be performed, as the part number and lot number are 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

It was reported that the patient underwent a revision surgery approximately 20 months post initial surgery due to pain.The surgeon noticed metallosis and a possible hairline fracture of tibial component during surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This report is being submitted to relay corrected information.Root cause remains undetermined.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.

• Brand Name: UNKNOWN FINN STEM
• 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: 7150647
• MDR Text Key: 95910260
• Report Number: 0001825034-2017-11363
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2018

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
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/02/2018; 01/04/2018
• Supplement Dates FDA Received: 01/03/2018; 01/04/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention