MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON; PROSTESIS, HIP

Catalog Number 11-301310

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device location is unknown.The investigation is in process.Once the investigation is complete, a follow ¿up mdr will be submitted.(b)(4).Concomitant medical products: item #11-301310/ arcos cone/ lot #333950.Item#11-300814 / arcos taper/ lot # 974700.Item# 11-107019/freedom const head/ lot #368920.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05801.

Event Description

It was reported that patient underwent bilateral patient underwent left hip revision 7 months post implantation due to disassociation as arcos cone body spun and head came off of stem.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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.Multiple mdr: 0001825034-2020-01559.

Event Description

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

• Brand Name: ARCOS CON
• Type of Device: PROSTESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9531418
• MDR Text Key: 185716353
• Report Number: 0001825034-2019-05799
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11-301310
• Device Lot Number: 333950
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 31 YR