MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LINER PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical devices: unknown- unknown, head-unknown; unknown- unknown, cup-unknown; unknown- unknown, stem-unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00381, 0001822565 - 2021 - 00382, 0001822565 - 2021 - 00384. Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product location unknown.

Event Description

It was reported that the patient is experiencing unknown issues post implantation; however, no revision has been reported to date. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11314481
• MDR Text Key: 231393748
• Report Number: 0001822565-2021-00383
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/02/2021
• 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: NI

Patient Treatment Data

Date Received: 02/11/2021 Patient Sequence Number: 1