MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DISCOVERY XS ELBOW LEFT HUMERAL FLANGED 3.5MM X 84MM; PROSTHESIS, ELBOW

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

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 or deviation.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 1 of 2 mdrs filed for the same patient (reference (b)(4)).

Event Description

Patient underwent an elbow revision approximately 3 years post-implantation due to loosening, wear and metallosis.Black tissue was observed.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product - xs discovery elbow humeral condyle kit 3.5 x 84 mm lt flange, catalog#: 114991, lot#: 803430.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 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.

• Brand Name: DISCOVERY XS ELBOW LEFT HUMERAL FLANGED 3.5MM X 84MM
• Type of Device: PROSTHESIS, 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 Key: 6215651
• MDR Text Key: 63640355
• Report Number: 0001825034-2016-05446
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK090473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CP561029
• Device Lot Number: 331530
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR