MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL RED LAT NC 8X120; PROSTHETIC, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis location unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.

Event Description

It was reported during the initial left hip stem implantation, the stem became stuck and needed to be removed.The surgeon could not attach the threaded removal tool instrument in to the stem and it was found that something must have been left in the stem from manufacturing.The surgery was completed with a new implant.A delay of ten minutes was reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.One echo por fmrl red lat nc 8x120 was returned and evaluated.Upon visual inspection, there was damage to the taper.There was a set screw returned inside of the stem which was removed.Length was measured to verify the size and found within conformance of the print.Review of the device history records identified no related deviations or anomalies during manufacturing medical records were not provided.The root cause was determined to be manufacturing deficiency as the set screw utilized during manufacturing was not removed.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.

Event Description

No further event information available at the time of this report.

• Brand Name: ECHO POR FMRL RED LAT NC 8X120
• Type of Device: PROSTHETIC, 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: 12347584
• MDR Text Key: 267441977
• Report Number: 0001825034-2021-02469
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304462908
• UDI-Public: (01)00880304462908(17)280411(10)935900
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 192508
• Device Lot Number: 935900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 12/29/2021
• Supplement Dates FDA Received: 12/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2018
• 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 Sex: Female