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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE ULNAR ASSEMBLY PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. INTERCHANGEABLE ULNAR ASSEMBLY PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Limited Mobility Of The Implanted Joint (2671)
Event Date 02/18/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 32810502604 interchangeable humeral assembly for cemented use only regular 63046695. Report source - foreign - (b)(6). The investigation is under progress. Once the investigation is completed a follow up report will be submitted.
 
Event Description
It was reported that the patient underwent a right elbow arthroplasty on unknown date and subsequently found through x-ray that the hinge was disconnected and found broken intra-operatively during a revision procedure. No additional information is available at this time.
 
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Brand NameINTERCHANGEABLE ULNAR ASSEMBLY
Type of DevicePROSTHESIS, ELBOW
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 Key8421451
MDR Text Key138818258
Report Number0001825034-2019-01099
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K001989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number32810505302
Device Lot Number63593894
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 Received03/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/06/2017
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: 03/14/2019 Patient Sequence Number: 1
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