MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAXIM PRIMARY DCM TIBIAL BEARING 14MM X 71/75MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 07/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).B3 - event date - unknown month and day in 2015; d6b - event date - unknown month and day in 2015.D10 - concomitant devices - unknown vanguard femoral component catalog #: ni lot #: ni, unknown vanguard tibial tray catalog #: ni lot #: ni, g2 - report source - foreign: event occurred in australia.The complainant has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2023-02842; 0001825034-2023-02843; 0001825034-2023-02844 h3 other text : investigation incomplete.

Event Description

It was reported that the patient underwent a left knee arthroplasty revision to address unknown complications post-operatively.Attempts have been made; however, no additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: concomitant devices: maxim porous primary femoral component 65mm left catalog#: 140072.Lot#: ni, biomet primary tibial tray 75mm, catalog#: 141214, lot#: ni, biomet finned primary stem 40mm, catalog#: 141314, lot#: ni.

Event Description

It was reported that the patient underwent a left knee arthroplasty revision to address pain and instability as a result of polyethylene wear approximately thirteen (13) years post-operatively.Attempts have been made; however, no additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Radiographs provided were reviewed and identified maintained implant fit with marked varus malalignment.The appearance was consistent with severe medial liner wear.The device history records could not be reviewed as the lot number associated with the reported event is unknown.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.

Event Description

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

• Brand Name: MAXIM PRIMARY DCM TIBIAL BEARING 14MM X 71/75MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18266100
• MDR Text Key: 329722832
• Report Number: 0001825034-2023-02844
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-146154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 142 KG