MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN ALL POLY PATELLA STANDARD CEMENTED SIZE 32 MM DIAMETER; 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.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.Articular surface with locking screw size ef 17 mm height catalog#: 00596404017 lot#: 60943356.Unknown palacos cement catalog#: 66017569 lot#: 81144418.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 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 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 ALL POLY PATELLA STANDARD CEMENTED SIZE 32 MM DIAMETER
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19031370
• MDR Text Key: 339225831
• Report Number: 0002648920-2024-00095
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K933785
• 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: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00597206532
• Device Lot Number: 62884635
• 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: 11/10/2014
• 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; Hospitalization
• Patient Sex: Male