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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH RIGHT ELBOW, PROSTHESIS

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ZIMMER BIOMET, INC. ULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH RIGHT ELBOW, PROSTHESIS Back to Search Results
Catalog Number 00840002407
Device Problem Loss of Osseointegration (2408)
Patient Problems Unspecified Infection (1930); Pain (1994)
Event Date 04/28/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: humeral screw, cat: 00840009000, lot: 62875490, humeral component, cat: 00840004410, lot: 62918648, articulation kit, cat: 00840009400, lot: 63020195. Foreign report source: (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up report will be submitted.
 
Event Description
It was reported that a patient underwent a right elbow revision due to loosening of the ulna component and there is suspicion of infection. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH RIGHT
Type of DeviceELBOW, 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 Key10034198
MDR Text Key190188168
Report Number0001822565-2020-01652
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00840002407
Device Lot Number63019947
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 05/07/2020 Patient Sequence Number: 1
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