MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ARTICULAR SURFACE; PROSTHESIS KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical product: unknown femoral component catalog # unknown lot # unknown unknown tibial component catalog # unknown lot # unknown g2: australia h3: customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a revision procedure post implantation due to unknown reason.Attempts to obtain additional information have been made; however, no more is available at this time.

• Brand Name: UNKNOWN ARTICULAR SURFACE
• 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: 19167374
• MDR Text Key: 340866195
• Report Number: 0001822565-2024-01379
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 04/23/2024

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female