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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALL POLY PATELLA SIZE 41 MM DIA. STANDARD 10.0 MM THICKNESS; PROSTHESIS, EXTREMITY
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ZIMMER BIOMET, INC. ALL POLY PATELLA SIZE 41 MM DIA. STANDARD 10.0 MM THICKNESS; PROSTHESIS, EXTREMITY Back to Search Results
Catalog Number 00597206541
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001822565 - 2019 - 02176.(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.
 
Manufacturer Narrative
Evaluation of the returned device identified sterility is not compromised.This device has not caused or contributed to a serious injury or a reportable malfunction.Please void this submission.
 
Event Description
Evaluation of the returned device identified sterility is not compromised.This device has not caused or contributed to a serious injury or a reportable malfunction.Please void this submission.
 
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Brand Name
ALL POLY PATELLA SIZE 41 MM DIA. STANDARD 10.0 MM THICKNESS
Type of Device
PROSTHESIS, EXTREMITY
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8629407
MDR Text Key145689487
Report Number0001822565-2019-02174
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
PMA/PMN Number
K933785 
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00597206541
Device Lot Number63395882
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2019
Was the Report Sent to FDA? No
Date Manufacturer Received09/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
00597206638, ALL POLY PATELLA LOT 63682387; 00597206638, ALL POLY PATELLA LOT 63682387
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