MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS STS DIST STEM 13X250MM M; PROSTESIS, HIP

Catalog Number 11-301013

Device Problems Degraded (1153); Separation Failure (2547)

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

Event Date 06/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product was requested but not returned by hospital.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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 concomitant medical products: item# 11-301304 /arcos con sz d std/ lot # 389230.Item # unknown / unknown screw/lot # unknown.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2021 - 02746.

Event Description

It was reported that the surgeon prepared and implanted the distal stem.The proximal reamer was used to prepare the proximal femur.The surgeon reamed up to d.The d 60 standard was implanted with the green proximal body inserter handle and then using the torque limiting t handle the screw was screwed down.Reduction was done with implants in place.The surgeon needed to change the version of the proximal body.He was handed the 3.5 driver to undo the screw and could not remove the screw it was stripped.He needed to remove the whole construct and replace the items with new ones.No adverse consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ARCOS STS DIST STEM 13X250MM M
• Type of Device: PROSTESIS, 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: 12541461
• MDR Text Key: 273639126
• Report Number: 0001825034-2021-02745
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304480346
• UDI-Public: (01)00880304480346(17)301204(10)932000
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2021

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 Catalogue Number: 11-301013
• Device Lot Number: 932000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2020
• 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