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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAESTRO TC CARPALHD 7X15MM STD TOTAL WRIST CARPUS PROSTHESIS

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ZIMMER BIOMET, INC. MAESTRO TC CARPALHD 7X15MM STD TOTAL WRIST CARPUS PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 09/24/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to location of device is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. This medwatch is associated with two other records: mdr #: 0001825034-2021-02776 and mdr #: 0001825034-2021-02774.
 
Event Description
It was reported patient underwent a revision procedure due to aseptic loosening. Attempts to obtain additional information have been made; however, no more is available at this time.
 
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Brand NameMAESTRO TC CARPALHD 7X15MM STD
Type of DeviceTOTAL WRIST CARPUS PROSTHESIS
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 Key12669667
MDR Text Key277624040
Report Number0001825034-2021-02773
Device Sequence Number1
Product Code JWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080426
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number180363
Device Lot Number452120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 10/20/2021 Patient Sequence Number: 1
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