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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN INTRAMEDULLARY STEM ELBOW, PROSTHESIS

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ZIMMER BIOMET, INC. UNKNOWN INTRAMEDULLARY STEM ELBOW, PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Date 05/05/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 211218, compr srs prox bdy - lg 42mm, unknown; unknown, unknown intercalary segment, unknown; unknown, unknown regenerex augment, unknown; unknown, unknown intramedullary stem, unknown; 211251, compr srs 60mm dst hml bdy lt, unknown; unknown, unknown pps augment, unknown; unknown, unknown seas head, unknown. Report source, foreign - the event occurred in the (b)(6). Reported event was unable to be confirmed due to limited information received from the customer. Device history record (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. 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. This report is being submitted late as it has been identified in remediation. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 01570; 0001825034 - 2018 - 01571; 0001825034 - 2018 - 01572; 0001825034 - 2018 - 01573; 0001825034 - 2018 - 01574; 0001825034 - 2018 - 01575; 0001825034 - 2018 - 01576. Product location unknown.
 
Event Description
It was reported that a patient underwent a right elbow arthroplasty. Subsequently, the patient experienced inability to open jar, inability to do heavy chores, inability to carry bag, inability to wash back, inability to cut, inability to do recreational activities, inability to perform social activities, moderate limitations in daily activities, moderate pain, and moderate difficulty sleeping. Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
(b)(4). This follow-up report is being submitted to relay additional information.
 
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Brand NameUNKNOWN INTRAMEDULLARY STEM
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 Key7302813
MDR Text Key101162893
Report Number0001825034-2018-01573
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received06/21/2018
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: 02/28/2018 Patient Sequence Number: 1
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