MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER; PROSTHETIC, HIP

Model Number N/A

Device Problem Separation Problem (4043)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: china.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the agent disassembled the ceramic head and assembled it into the bipolar head in the correct way.After the doctor implanted the product, he found that the femoral head could not be fixed on stem stably and formed a taper locking.There was a 70 minute delay in the surgery.Prolonged anesthesia time and increased blood transfusion.

Manufacturer Narrative

Supplemental report provided as an update was provided to the complaint description (b5) that was previously reported under mfr#: 0001822565-2022-03446.

Event Description

It was reported that the doctor assembled the ceramic head into the bipolar head in the correct way.After the doctor implanted the product, he found that the femoral head and the shank cone could not form a taper lock and the fixation was unstable.There was a 70-minutes delay in this surgery with prolonged anesthesia time and increased blood transfusion.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: d6b: device remains implanted.H6: proposed component code: mechanical (g04)-stem.Visual examination of the provided videos in the linked complaint identified the head was loose on the stem taper.No further evaluation can be made from the provided videos.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined for the head and stem not locking together.The increased blood transfusion/blood loss was determined to be procedure related after review by a hcp.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

There is no update to the previous complaint description provided.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15961921
• MDR Text Key: 305326703
• Report Number: 0001822565-2022-03446
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024131750
• UDI-Public: (01)00889024131750(17)320515(10)65353315
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K192660
• 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,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00771100910
• Device Lot Number: 65353315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 01/03/2023; 01/18/2023
• Supplement Dates FDA Received: 01/04/2023; 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male