MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CONE TRIAL; INSTRUMENT, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2023

Event Type  malfunction  

Event Description

It was reported that the cone trial was detaching from the stem.This resulted in the screwdriver becoming fractured when attempting to remove the cone trial.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).D10: 31-301852 item name arcos 3.5mm hex drive lot # zb7276048 00-6260-024-00 str screwdriver 3.5mm hex long lot 78269400 multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2023 - 02593 the device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device location is unknown.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - stem.No cone trial product was returned, or pictures provided.Medical records were not provided.A visual inspection of the returned arcos hex drive showed that the tip of the device had fractured.There were visible wear lines near the fracture location.The features of the fracture surface visually align with a torsional overload fracture.The cone body was not returned so no evaluation could be completed on that item.A compatibility check could not be performed due to insufficient information.The issue of fracture was confirmed via the returned hex drive; however, the locked components were not confirmed.A definitive root cause could not be determined.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 is available at the time of this report.

• Brand Name: UNKNOWN CONE TRIAL
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18074006
• MDR Text Key: 327413540
• Report Number: 0001825034-2023-02594
• Device Sequence Number: 1
• Product Code: LXH
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10
• Patient Sex: Prefer Not To Disclose