MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 15X150MM SPL TPR DIST; POSTHESIS, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problems Pain (1994); No Information (3190)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date - (b)(6) 2019.Concomitant medical products: catalog#: 11-301322 arcos con sz b std 70mm lot#: 629570.Catalog#: 650-1161 delta cer fem hd 32/+3mm t1 lot#: 2016110787.Report source: foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to device being discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02149.

Event Description

It was reported that the patient underwent a revision procedure approximately 1 year post implantation due to pain and stem subsidence.The cone body, distal stem and modular head were removed and replaced.No further event information available at the time of this report.

• Brand Name: ARCOS 15X150MM SPL TPR DIST
• Type of Device: POSTHESIS, 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: 10586381
• MDR Text Key: 208545312
• Report Number: 0001825034-2020-02150
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-300815
• Device Lot Number: 137490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2019
• 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 Outcome(s): Hospitalization; Required Intervention