MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CR TIB BRG 10X63/67; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094)

Event Date 09/07/2023

Event Type  Injury  

Event Description

It was reported that a patient was revised due to instability, implant wear, pain and synovitis.

Manufacturer Narrative

(b)(4).H3- customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, and h10 no product was returned; therefore, visual and dimensional evaluations could not be performed.Visual evaluation of the provided photo found evidence of use (surgical debris).Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: coronal instability mid flexion, marked synovitis with synovectomy performed, femoral/tibia/patella components well fixed, no complications noted.Radiographs were provided and reviewed by a health care professional.The radiographs were not submitted as there is sufficient documentation of the event within the operative notes.Submission at this time would not enhance the investigation.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.This complaint has been confirmed by review of the provided medical records and provided photo.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VNGD CR TIB BRG 10X63/67
• 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: 17817268
• MDR Text Key: 324249627
• Report Number: 0001825034-2023-02238
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K023546
• 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
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 183420
• Device Lot Number: 243090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2009
• 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: Female