MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ C STD 70MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Mechanical Problem (1384); Difficult To Position (1467)

Patient Problem No Information (3190)

Event Date 11/20/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign: the event occurred in (b)(6).Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to 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.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that a female patient underwent right hip revision surgery on (b)(6) 2014.During the surgery, the surgeon reported difficulty in locking the screw between cone and distal body components.The surgeon left it "untight" and stated the patient tolerated this.No injuries were reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information. concomitant medical products:catalog number:22-300914 lot number:419040 brand name:arcos 14x190mm spl tpr dist.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00466.No medical records received.X-ray review noted the overall fit and alignment of the implant is appropriate.Possible osteopenia.There is suggestion of possible lucency involving the medial cortex of the left proximal femoral diaphysis which may represent an incomplete fracture but is poorly evaluated on these images.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.The additional information does not change the results of the previous investigation.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.Device not returned for evaluation.

Event Description

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

• Brand Name: ARCOS CON SZ C STD 70MM
• 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: 7371853
• MDR Text Key: 103691231
• Report Number: 0001825034-2017-09926
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/04/2023
• Device Model Number: N/A
• Device Catalogue Number: 22-301323
• Device Lot Number: 915020
• Other Device ID 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: 01/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2013
• 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
• Patient Age: 82 YR
• Patient Weight: 79