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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. UNKNOWN SUBCHONDROPLASTY PRODUCT BONE SUBSTITUTE

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ZIMMER KNEE CREATIONS, INC. UNKNOWN SUBCHONDROPLASTY PRODUCT BONE SUBSTITUTE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported that a patient had underwent a subchondroplasty procedure on an unknown date. Subsequently, the patient was revised to a tka system due to unknown reasons. Attempts have been made and no further information has been provided.

 
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Brand NameUNKNOWN SUBCHONDROPLASTY PRODUCT
Type of DeviceBONE 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
shari bailey
841 springdale drive
exton, PA 19341
4848794543
MDR Report Key8549237
MDR Text Key143055829
Report Number3008812173-2019-00024
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN SUBCHONDROPLASTY
Device LOT NumberUNKNOWN
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 Received03/27/2019
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
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 04/25/2019 Patient Sequence Number: 1
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