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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.
 
Manufacturer Narrative
Upon reassessment of the reported event it was determined that the report was submitted on the wrong mfr number.The initial report submitted needs to be voided.The event will be reported on 0001822565 - 2019 - 01419.
 
Event Description
Upon reassessment of the reported event it was determined that the report was submitted on the wrong mfr number.The initial report submitted needs to be voided.The event will be reported on 0001822565 - 2019 - 01419.
 
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Brand Name
INTERCHANGEABLE ULNAR ASSEMBLY
Type of Device
PROSTHESIS, ELBOW
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8421451
MDR Text Key138818258
Report Number0001825034-2019-01099
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
K001989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2022
Device Model NumberN/A
Device Catalogue Number32810505302
Device Lot Number63593894
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/18/2019
Initial Date FDA Received03/14/2019
Supplement Dates Manufacturer Received03/11/2019
Supplement Dates FDA Received04/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age71 YR
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