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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SRS RIGHTSEGMENTAL STEM W/INTERLOCKING HOLES AND SCREW 71MM X 13MM PROSTHESIS, ELBOW

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BIOMET ORTHOPEDICS COMPREHENSIVE SRS RIGHTSEGMENTAL STEM W/INTERLOCKING HOLES AND SCREW 71MM X 13MM PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur under possible adverse effects, number 11 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption or excessive activity. " this report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2015-03687 / 1825034-2016-04305).
 
Event Description
Patient has been indicated for a right elbow revision procedure due to the screws backing out. No revision has been reported to date.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. (b)(6). (b)(4). Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. Root cause remains 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.
 
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Brand NameCOMPREHENSIVE SRS RIGHTSEGMENTAL STEM W/INTERLOCKING HOLES AND SCREW 71MM X 13MM
Type of DevicePROSTHESIS, ELBOW
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key6061867
MDR Text Key58598622
Report Number0001825034-2016-04305
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
PCUSTOM
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 03/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberCP562277
Device Lot Number863200
Other Device ID NumberSEE H10 NARRATIVE
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 Received02/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2016
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: 10/27/2016 Patient Sequence Number: 1
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