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 Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02737, 0001822565-2022-02739.

Event Description

It was reported that the patient underwent a left knee arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision due to unknown reasons.The sales rep was inquiring about patient matched implants.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

Event Description

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• 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: 15485158
• MDR Text Key: 300567982
• Report Number: 0001822565-2022-02738
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

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
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 10/18/2022
• 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
• Patient Outcome(s): Other