MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZMR CONE BODY PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Osteopenia/ Osteoporosis (2651); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical devices: item #: unknown, unknown liner, lot #: unknown; item #: unknown, unknown stem, lot #: unknown; item #: unknown, unknown cup, lot #: unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03121, 0001822565 - 2020 - 03123, 0001822565 - 2020 - 03124.

Event Description

It was reported that patient underwent an initial left total hip arthroplasty and has now been indicated for a revision approximately 8 years post primary implantation. However, a revision has not been reported. The sales rep was inquiring about implant identification. Attempts have been made and no further information has been provided.

• Brand Name: UNKNOWN ZMR CONE BODY
• 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: 10484022
• MDR Text Key: 205341896
• Report Number: 0001822565-2020-03122
• 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: distributor,health profession

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

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: 09/11/2020
• 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: Invalid Data
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 09/02/2020 Patient Sequence Number: 1