• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. ARCOS CON SZ A STD 50MM; PROSTHESIS, HIP Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event 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 Key8055002
MDR Text Key127133214
Report Number0001825034-2018-10516
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K090757
Number of Events Reported1
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 Date09/30/2020
Device Model NumberN/A
Device Catalogue Number11-301300
Device Lot Number948460
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/13/2018
Initial Date FDA Received11/09/2018
Supplement Dates Manufacturer Received11/16/2018
Supplement Dates FDA Received11/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
11-300815 274920 ARCOS 15X150MM SPL TPR DIST
Patient Weight64
-
-