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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ B STD 60MM TRL PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ARCOS CON SZ B STD 60MM TRL 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 Type  Malfunction  
Manufacturer Narrative

(b)(4). Concomitant medical products: catalog#: 31-300818, arcos 18 x 150mm sts stem trl, lot#: 843340. Catalog#: 31-300918, arcos 18 x 190mm sts stem trl, lot#: 835540. Catalog#: 31-301300, arcos con sz a std 50mm trl, lot#: 422427. Foreign: (b)(6). Product has been received by zimmer biomet and 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: 0001825034-2019-05671, 0001825034-2019-05672.

 
Event Description

It was reported that the proximal body would not disengage from the stem. Attempts have been made and additional information on the reported event is unavailable at this time.

 
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Brand NameARCOS CON SZ B STD 60MM TRL
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 Key9500366
MDR Text Key206879431
Report Number0001825034-2019-05677
Device Sequence Number1
Product Code KWA
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK100469
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number31-301302
Device LOT Number429960
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/11/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/04/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/08/2015
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

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