MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RECAP CEMENT FMRL HD RESUR44MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Synovitis (2094); Reaction (2414)

Event Date 03/31/2014

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Multiple mdr's were submitted for this event.Please see associated report(s): 0001825034-2018-02469.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient was revised to address pain.Synovitis, patulous capsule, and metallosis were identified intraoperatively.Attempts have been made and no further information has been made available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: RECAP CEMENT FMRL HD RESUR44MM
• 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: 7428224
• MDR Text Key: 105370306
• Report Number: 0001825034-2018-02471
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK021799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 157244
• Device Lot Number: 082800
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2004
• 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): Hospitalization; Required Intervention