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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 20X190MM SPL TPR DIST HA X 190MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ARCOS 20X190MM SPL TPR DIST HA X 190MM PROSTHESIS, HIP Back to Search Results
Catalog Number 22300920
Device Problem Difficult or Delayed Separation
Event Date 07/05/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: 22-300920 lot 261390 arcos sts 20x190 mm, 31-301303 lot 199930 arcos cone trial c std 60 mm, 31-301852 lot 170201 hex drive 3,5 mm, 31-301852 lot 120701 hex drive 3,5 mm. Report source: (b)(6). Multiple mdr's were filed for this event: 0001825034 - 2019 - 03359, 0001825034 - 2019 - 03267, 0001825034 - 2019 - 03360, 0001825034 - 2019 - 03361, 0001825034 - 2019 - 03363. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.

 
Event Description

After implanting an arcos sts stem the trial cone body was locked on the stem in accordance with the surgical technique. When trying to unlock the trial cone body, the screwdriver broke inside the patient. The stem and trial body was explanted, and an attempt to disengage the trial body was made with a new screwdriver, which also broke. The third attempt yielded another broken driver. A surgical delay of 60 minutes was reported. No further information is available at the time of this reporting.

 
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Brand NameARCOS 20X190MM SPL TPR DIST HA X 190MM
Type of DevicePROSTHESIS, 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 Key8849447
Report Number0001825034-2019-03359
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/06/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number22300920
Device LOT Number261390
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/30/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/25/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 08/01/2019 Patient Sequence Number: 1
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