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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 23X250MM SPL TPR DIST; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. ARCOS 23X250MM SPL TPR DIST; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Multiple mdrs were filed for this event.Please see associated: 0001825034-2019-03528.(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified.No patient or surgical involvement.No further information available at this time.
 
Event Description
It was determined this device did not cause or contribute to a serious injury and has not been identified as a reportable malfunction.Please void this submission.
 
Manufacturer Narrative
It was determined this device did not cause or contribute to a serious injury and has not been identified as a reportable malfunction.Please void this submission.
 
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Brand Name
ARCOS 23X250MM SPL TPR DIST
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8887269
MDR Text Key195043268
Report Number0001825034-2019-03529
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
K090757
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 11/11/2019
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 Model NumberN/A
Device Catalogue Number11-301023
Device Lot Number959740
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/07/2019
Initial Date FDA Received08/13/2019
Supplement Dates Manufacturer Received11/05/2019
Supplement Dates FDA Received11/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
11-301023 ARCOS TPR, LOT 049390
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