MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Hematoma (1884); Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 42540000035, poly patella, lot # 64422826, 42502806602, femur, lot # 64488558, 42522100911, articular surface, lot # 64386018.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2019 - 00890, 0001822565 - 2019 - 05211, 0001822565 - 2019 - 05213.

Event Description

It was reported that approximately 2 weeks post implantation, the patient had developed a hematoma and had it aspirated.Patient also had complaints of decreased flexion due to pain and swelling.Attempts have been made and no additional information has been provided.

Event Description

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

Manufacturer Narrative

The product was evaluated through manufacturing review and the reported event was confirmed through review of records provided.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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: NATURAL TIBIA TRABECULAR METAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9440391
• MDR Text Key: 170005050
• Report Number: 0001822565-2019-05212
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 008809024510609
• UDI-Public: (01)008809024510609
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• 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: 42530007902
• Device Lot Number: 64175463
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 101