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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. ZSS DISTAL FEMORAL XT COMPONENT SIZE C LEFT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/09/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Foreign (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that during surgery it was found out that some of the implants in the loaner set were delivered unsterile. Packaging box was closed with additional transparent adhesive tape. With same tape was closed first plastic box inside, white top cover paper was not hermetically closed. Attempts have been made and no further information has been provided.
 
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Brand NameZSS DISTAL FEMORAL XT COMPONENT SIZE C LEFT
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 Key9979663
MDR Text Key196633785
Report Number0001822565-2020-01420
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 10/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00585004301
Device Lot Number64360106
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? Device Not Returned to Manufacturer
Date Device Manufactured07/03/2019
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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