MAUDE Adverse Event Report: ZIMMER TMT NEXGEN TRABECULAR METAL CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT SIZE 4 C-H; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Fall (1848); Pain (1994); Swelling (2091); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: nexgen porous femoral component size d right, catalog #: 00597201402, lot #: 62685909.Nexgen trabecular metal standard primary patella 32mm, catalog #: 00587806532, lot #: 62767097.The device was evaluated through manufacturing review, however, the reported event could not be confirmed with the information provided.The device history records were reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could be determined due to limited information received from the customer.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 patient; please see all reports associated with this event: 0001822565-2018-04594, 3005751028-2020-00028.This complaint has been reassessed as part of ca-(b)(4).It was determined that additional regulatory reporting is required.

Event Description

It is reported that the patient has experienced pain, swelling, numbness and loss of balance, which has led to multiple falls approximately three (3) years following knee arthroplasty.Attempts have been made and no additional information is available.

• Brand Name: NEXGEN TRABECULAR METAL CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT SIZE 4 C-H
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: william hara ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 9992910
• MDR Text Key: 189148570
• Report Number: 3005751028-2020-00032
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2020

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 Expiration Date: 05/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 00588604414
• Device Lot Number: 61769569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2011
• 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): Other
• Patient Weight: 100