MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A STD 50MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date sometime in 2011.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to device remains implanted.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: 0001825034-2018-10515.

Event Description

It was reported that the arcos stem could not be disengaged at modular junction, and the device was clearly well fixed.Decision was made intraoperatively that morbidity of performing an extended trochanteric osteotomy was not warranted.The femoral component was retained.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 confirmed by review of medical records received.Right hip revision op note demonstrated that the patient had revision due to infection.During the revision, the abductors were found destroyed.The screw was removed.However, the proximal body cannot be removed.Therefore the stem was not revised.Dhr was reviewed and no discrepancies relevant to the reported event 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.

Event Description

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

• Brand Name: ARCOS CON SZ A STD 50MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8055002
• MDR Text Key: 127133214
• Report Number: 0001825034-2018-10516
• 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: health professional,study
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

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 Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 11-301300
• Device Lot Number: 948460
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 11/16/2018
• Supplement Dates FDA Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 11-300815 274920 ARCOS 15X150MM SPL TPR DIST
• Patient Weight: 64