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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ C STD 70MM; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. ARCOS CON SZ C STD 70MM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Remove (1528)
Patient Problem No Information (3190)
Event Date 01/15/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Unknown taper.Unknown 60mm taper disassembly tool customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001822565 - 2021 - 00363.
 
Event Description
It was reported that during the procedure when using 60mm taper disassembly tool, the surgeon was unable to extract the taper from distal stem.His next option was to perform an extend trochanter osteotomy to remove the stem, taper, and disassembly tool in one piece.No additional information.
 
Event Description
It was further reported that the instrument was cross threaded in the cone body.Therefore, the surgeon was forced to perform an extend trochanter osteotomy to remove the stem, taper, and disassembly tool in one piece.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
 
Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 1825034.
 
Event Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
 
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Brand Name
ARCOS CON SZ C STD 70MM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11310892
MDR Text Key231308245
Report Number0001822565-2021-00364
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 distributor,health profession
Type of Report Initial,Followup,Followup,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number11-301323
Device Lot Number213330
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE.
Patient Outcome(s) Required Intervention;
Patient Age45 YR
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