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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL FEMORAL XT COMPONENT SIZE C RIGHT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. DISTAL FEMORAL XT COMPONENT SIZE C RIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 04/09/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source - (b)(6). Customer has indicated that the product will 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.
 
Event Description
It was reported that some of the implants in the loaner set were delivered unsterile. The packaging box was closed with additional transparent adhesive tape. The first plastic box inside was closed with the same tape. The white top cover paper was not hermetically closed. Second plastic box´s top cover paper was opened too. There is no additional information available at this time.
 
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Brand NameDISTAL FEMORAL XT COMPONENT SIZE C RIGHT
Type of DevicePROSTHESIS, KNEE
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 Key9980859
MDR Text Key197323317
Report Number0001822565-2020-01419
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeEN
PMA/PMN Number
K150028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00585004302
Device Lot Number64360051
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

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