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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. KNEE CREATIONS SUBCHONDROPLASTY ACCUFILL FOOT & ANKLE KIT 3CC 15G BONE MATERIAL SUBSTITUTE

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ZIMMER KNEE CREATIONS, INC. KNEE CREATIONS SUBCHONDROPLASTY ACCUFILL FOOT & ANKLE KIT 3CC 15G BONE MATERIAL SUBSTITUTE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 07/20/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device is an injectable material in the patient. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It is reported that there is potential harm being alleged for this device, however, the nature of the harm is unknown at this time. Attempts have been made to obtain additional information, however, no additional information is available at this time.

 
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Brand NameKNEE CREATIONS SUBCHONDROPLASTY ACCUFILL FOOT & ANKLE KIT 3CC 15G
Type of DeviceBONE MATERIAL SUBSTITUTE
Manufacturer (Section D)
ZIMMER KNEE CREATIONS, INC.
841 springdale drive
exton PA 19341
Manufacturer (Section G)
ZIMMER KNEE CREATIONS, INC.
841 springdale drive
exton PA 19341
Manufacturer Contact
leo munar
841 springdale drive
exton, PA 19341
4848794553
MDR Report Key10501100
MDR Text Key205890349
Report Number3008812173-2020-00014
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number514.315
Device LOT NumberKC06661
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 Received11/03/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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

Patient TREATMENT DATA
Date Received: 09/08/2020 Patient Sequence Number: 1
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