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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPR SRS 60MM DST HUM BDY LT PROSTHESIS, ELBOW

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BIOMET ORTHOPEDICS COMPR SRS 60MM DST HUM BDY LT PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problem Joint Dislocation (2374)
Event Date 02/06/2017
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Complaint x ray¿s were evaluated and the reported event was confirmed. Dhr was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required. An x-ray was provided and reviewed. The results of the review identified the following: "comprehensive segmental distal humeral/elbow reconstruction prostheses are present. The humeral distal body component is completely dissociated from the humeral stem component, and is displaced medially. A stabilizing plate and screw are not identified in the vicinity of junction of humeral stem and body components. " 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 medical products - compr srs anti rot ic seg-30mm, cat#: 211266, lot#: 515410; compr srs mod stem - 10x100mm, cat#: 211237, lot#: 871110; humeral screw kit 2 humeral screws, cat#: 00840009000, lot#: 63425387; articulation kit size 5/6 1 axle pin, 1 humeral bearing a, 2 ulnar bearings b, cat#: 00840009500, lot#: 63396483; compr srs large flange, cat#: 211270, lot#: 231150; elbow torque driver, cat#: 00840108000, lot#: 56613805; compr srs ic seg - 60mm, cat#: 211225, lot#: 104420. Concomitant medical products ¿ therapy date ¿ unknown date in (b)(6) 2017. Customer has indicated that the product will not be returned [as it remains implanted at the time of this report] to zimmer biomet for investigation. 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 reports:1825034-2017-01558 / 01566.
 
Event Description
It has been reported that the patient underwent a left elbow arthroplasty and approximately 12 days post-implantation the patient stated hearing a clicking sound. Radiographs reveal that the humeral component has failed and separated from the intercalary segment. No revision has been reported to date. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameCOMPR SRS 60MM DST HUM BDY LT
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 Key6403997
MDR Text Key113330517
Report Number0001825034-2017-01558
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
PK153398
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 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number110029825
Device Lot Number115510
Other Device ID NumberSEE NARRATIVE IN 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 Received11/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2016
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: 03/14/2017 Patient Sequence Number: 1
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