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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS XS DISCOVERY ELBOW HUMERAL CONDYLE KIT 3.5X84MM LT FLANGE PROSTHESIS, ELBOW

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BIOMET ORTHOPEDICS XS DISCOVERY ELBOW HUMERAL CONDYLE KIT 3.5X84MM LT FLANGE PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problems Migration or Expulsion of Device (1395); Naturally Worn (2988)
Patient Problem Reaction (2414)
Event Date 11/21/2016
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Concomitant medical product - discovery xs elbow left humeral flanged 3. 5 mm x 84 mm, catalog#: cp561029, lot#: 331530. Complaint sample was evaluated and the reported event was confirmed. There is no bony ingrowth on the stem of the humeral component. There are portions of the stem where it appears the coating is worn away. There are significant scratches and abrasions on the humeral component just proximal to the stem. The male and female condyles that were returned were observed to have circular wear marks around the entire circumference. The ulnar component and condyle lock screws were not returned and therefore, could not be evaluated. Dimensional analysis was not performed on the devices due to the damage which would cause inaccuracies in the data. X-rays were received and reviewed. The results identified: "angulation with ventral migration proximal humeral stem component. Lack of placement of a bone graft beneath the anterior flange of the humeral component may have increased force on the distal portion of the humeral component, resulting in migration/angulation of the humeral component. " device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action(s) is/are required. 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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Device history record was reviewed and no discrepancies relevant to the reported event were found. 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.
 
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show the lot released with no recorded anomaly. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "material sensitivity reactions. " number 6 states, "loosening, migration, and/or fracture of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and/or excessive activity. " number 13 states, "wear and/or deformation of articulating surfaces. " this report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2016-05446 / 05447).
 
Event Description
Patient underwent an elbow revision approximately 3 years post-implantation due to loosening, wear and metallosis. Black tissue was observed.
 
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Brand NameXS DISCOVERY ELBOW HUMERAL CONDYLE KIT 3.5X84MM LT FLANGE
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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6215652
MDR Text Key106910501
Report Number0001825034-2016-05447
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK090473
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 10/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number114991
Device Lot Number803430
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2013
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: 12/30/2016 Patient Sequence Number: 1
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