MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMT 360 TIB LG CRUCIATE WING; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Increased Sensitivity (2065); Swelling (2091); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 185264, vngd ssk 360 r fem 65mm, 6082525; 145006, biomet smooth knee stems 16x40, 693670; 185211, bmt 360 tib 5.0 offset adapter, 881810; 185084, vngd ssk ps tib brg 14x71/75, 299930; 185210, bmt 360 2.5mm offset adapter, 550180; 185203 bmt 360 tibial tray 71mm 392640.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: 0001825034-2018-03680, 0001825034-2018-03681, 0001825034-2018-03757, 0001825034-2018-03758, 0001825034-2018-03760, 0001825034-2018-03761.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.Device remains implanted in patient.

Event Description

It was reported that the patient underwent a right knee revision procedure and subsequently is now experiencing pain, swelling, sensitivity, and may be having a possible allergic reaction to the implants.It is further reported that the patient has stabbing pain in the grown area to mid shin.Attempts have been made and additional information on the reported event is unavailable.

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) was reviewed and no discrepancies relevant to the reported event were found.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: BMT 360 TIB LG CRUCIATE WING
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7562310
• MDR Text Key: 109836895
• Report Number: 0001825034-2018-03759
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK140883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• 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: 185651
• Device Lot Number: 700880
• Other Device ID Number: (01) 00880304525764
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 113