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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DISCOVERY ELBOW SYSTEM EXTRA SMALL HUMERAL CONDYLE KIT PROSTHESIS, ELBOW

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BIOMET ORTHOPEDICS DISCOVERY ELBOW SYSTEM EXTRA SMALL HUMERAL CONDYLE KIT PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)
Patient Problem Reaction (2414)
Event Date 02/28/2017
Event Type  Injury  
Manufacturer Narrative
Reported event was unable to be confirmed. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of complaint history determined that no further action is required as no trends were identified. 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
(b)(4). Concomitant products: medical device-disc hum 3. 5x124mm lt flange c item#:114912 lot#:510780 customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated report: 0001825034-2017-03357.
 
Event Description
It is reported that the patient underwent a total elbow arthroplasty revision approximately ten (10) months post-implantation due to screw loosening with onset approximately seven to eight (7-8) months post-operatively. During the revision, the surgeon noted metallosis inside the joint.
 
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Brand NameDISCOVERY ELBOW SYSTEM EXTRA SMALL HUMERAL CONDYLE KIT
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 Key6578086
MDR Text Key195037787
Report Number0001825034-2017-03356
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeKS
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
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2017
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 Number665670
Other Device ID NumberREFERENCE H10
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 Received02/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2016
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: 05/19/2017 Patient Sequence Number: 1
Treatment
REFERENCE H10
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