MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET UNKNOWN MH RINGLOC SHELL PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Hematoma (1884)

Event Date 02/14/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Unique identifier (udi) #: n/a. Concomitant medical products: item # unk , stem, lot # unk; item # 157454, head, lot # unk; item # unk, liner, lot # unk. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 05655; 0001825034 - 2018 - 05656; 0001825034 - 2018 - 05658.

Event Description

It was reported that approximately 3 weeks post implantation, the patient underwent an i&d of a hematoma with positive cultures. Attempts have been made and no further information has been provided.

• Brand Name: BIOMET UNKNOWN MH RINGLOC SHELL
• 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: 7761746
• MDR Text Key: 116388907
• Report Number: 0001825034-2018-05657
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• 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?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/30/2019
• 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

Patient Treatment Data

Date Received: 08/08/2018 Patient Sequence Number: 1