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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN DISCOVERY ULNAR COMPONENT PROSTHESIS, EXTREMITY

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ZIMMER BIOMET, INC. UNKNOWN DISCOVERY ULNAR COMPONENT PROSTHESIS, EXTREMITY Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Fracture, Arm (2351); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Adverse event only. Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown. Dhr review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that the patient had an initial left elbow arthroplasty on unknown date. Subsequently, a custom proximal ulna replacement with discovery modular coupling has been requested due to peri-prosthetic ulnar fracture. No further information has been provided.
 
Manufacturer Narrative
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient had an initial left elbow arthroplasty on unknown date. Subsequently, the pmi group is requesting a proximal ulna replacement with discovery modular coupling for a revision on an unknown date. The patient has a peri implanted fracture of the ulna with the ulna revision stem. No further information has been provided.
 
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Brand NameUNKNOWN DISCOVERY ULNAR COMPONENT
Type of DevicePROSTHESIS, EXTREMITY
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 Key6951169
MDR Text Key110918458
Report Number0001825034-2017-08761
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2017
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 Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 10/16/2017 Patient Sequence Number: 1
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