MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM - REVISION TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 12/08/2021

Event Type  Injury  

Event Description

It was reported that the patient was revised due to stem fracture approximately 7 years post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Report source: source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

Review of the device history record identified no deviations or anomalies during manufacturing.This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h1, h2, h3, h6, h10.Reported event was unable to be confirmed.Review of the device history record identified no deviations or anomalies during manufacturing.Root cause could not 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: FEMORAL STEM - REVISION TAPER
• 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: 13012728
• MDR Text Key: 282490064
• Report Number: 0001822565-2021-03597
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 00889024160880
• UDI-Public: (01)00889024160880(17)230531(10)62370367
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K992667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00998201918
• Device Lot Number: 62370367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2013
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention