MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD DIST FEM AUG 70X5 RL/LM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Aspiration/Inhalation (1725); Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-11562, 0001825034-2018-11563, 0001825034-2019-03842, 0001825034-2019-03846.Concomitant medical products: vngd ti fem ssk 70mm lt, catalog#: cp113127, lot#: 142810, vanguard ssk ps tibial bearing, catalog #: 185082, lot #: 254570, vngd dist fem aug 70x5 ll/rm catalog#: 184126 lot#: 115820, biomet splined knee stem, catalog #: 148321, lot #: 730560, biomet offset tibial tray adaptor, catalog #: 141491, lot #: 668350, biomet offset tibial tray with locking bar, catalog #: 141483, lot #: 289850, biomet splined knee stem, catalog #: 148305, lot #: 040880.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.

Event Description

It was reported patient underwent left knee revision procedure for elevated metal ions levels.Subsequently, the patient had to under go manipulation six (6) weeks post operative as the knee was not bending as much as required.The patients states that the knee was damaged during manipulation by the surgeon.Now at twelve (12) weeks later the patient experiences bruises, experiencing pain and attributed to limited range of motion.No additional information is available.

• Brand Name: VNGD DIST FEM AUG 70X5 RL/LM
• 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: 8962199
• MDR Text Key: 156560189
• Report Number: 0001825034-2019-03842
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2019

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 Expiration Date: 11/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 184106
• Device Lot Number: 258290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2008
• 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): Required Intervention