MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET MODULAR TIBIAL LOCKING BAR; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: vanguard dcm tibial bearing cat#: 183888, lot#: 205660; biomet offset tibial tray cat#: 141483, lot#: 482440; vanguard ssk femoral component cat#: 183304, lot#: 220670; biomet splined knee stem v2 cat#: 148321, lot#: 661140; biomet splined knee stem v2 cat#: 148308, lot#: 978960; vanguard series-a standard patella cat#: 184764, lot#: 986750; biomet offset tibial tray adaptor cat#: 141491, lot#: 221940; vanguard femoral distal augment cat#: 184204, lot#: 747090; vanguard femoral-rl/lm distal augment cat#: 184184, lot#: 046490; biomet modular tibial augmentation block cat#: 141763, lot#: 222670; biomet modular tibial augmentation block cat#: 141763, lot#: 222670.The product has not been returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 11375, 0001825034 - 2017 - 11376, 0001825034 - 2017 - 11377, 0001825034 - 2017 - 11378, 0001825034 - 2017 - 11379, 0001825034 - 2017 - 11380, 0001825034 - 2017 - 11381, 0001825034 - 2017 - 11382, 0001825034 - 2017 - 11383, 0001825034 - 2017 - 11384, 0001825034 - 2017 - 11385, 0001825034 - 2017 - 11386.Product location is unknown.

Event Description

It was reported that the patient was revised two months after knee procedure due to unknown reasons.

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 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.

• Brand Name: BIOMET MODULAR TIBIAL LOCKING BAR
• 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: 7142015
• MDR Text Key: 95617390
• Report Number: 0001825034-2017-11376
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 141205
• Device Lot Number: 516560
• Other Device ID Number: (01)00880304009738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2017
• 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