MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW SIZE EF 17 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 03/23/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03582, 0002648920-2023-00301, 0002648920-2024-00094, 3007963827-2024-00096, 0001822565-2024-01122, and 0002648920-2024-00095.D10 medical devices: tibial block and screws precoat size 5 5 mm thickness catalog#: 00598800526 lot#: 60534032 modular tibial plate fixed bearing precoat size 5 catalog#: 00598004701 lot#: 62868646 15mm diameter 30mm length straight stem extension catalog#: 00598801215 lot#: 62925965 femoral component option size f catalog#: 00599601601 lot#: 62835028 all poly patella standard cemented size 32 mm diameter 8.5 mm thickness catalog#: 00597206532 lot#: 62884635.Unknown palacos cement catalog#: 66017569 lot#: 81144418.G2 foreign source: united kingdom.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.Review of complaint history found no additional related issues for the reported part and lot combinations.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 that patient underwent a left knee procedure.Following the procedure, the patient reported pain, inflammation, swelling, difficulty ambulating, and stiffness.The patient underwent a revision of the knee approximately eight years post implantation.During the revision, instability was noted under the components.

• Brand Name: NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW SIZE EF 17 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19031357
• MDR Text Key: 339225166
• Report Number: 0001822565-2024-01122
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K991581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

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: 03/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 00596404017
• Device Lot Number: 60943356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2008
• 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
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male