MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS TAPER DISASMBLY 50MM; INSTRUMENT, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-301310 arcos con sz a hi 50mm lot number: 841860 report source: foreign: canada.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00828 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, as supplemental medwatch will be submitted.Device location is unknown.

Event Description

It was reported that during a procedure that while unscrewing, the taper tool disengaged itself from cone.The tool ate the threading of the cone, and it was now impossible to screw back the taper tool in the cone.Surgeon inserted the cone and verified if the femoral stem was well fixated(¿it was) and decided to leave cone that was still attached to distal stem and put the lock screw back in.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.Visual examination of the provided pictures shows the removal tool with a piece of metal debris on the table.Its unknown if the metal debris is part of the removal tool.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot 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

There is no update to the prior event description provided.

• Brand Name: ARCOS TAPER DISASMBLY 50MM
• 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: 16755679
• MDR Text Key: 313450302
• Report Number: 0001825034-2023-00827
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00887868477928
• UDI-Public: (01)00887868477928(11)160613(10)ZB160202
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• 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: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• 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: 31-301856
• Device Lot Number: ZB160202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2016
• 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
• Patient Age: 73 YR
• Patient Sex: Female