MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISCOVERY XS HUMERAL 3.5X84MM RIGHT FLANGE; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Metal Shedding Debris (1804)

Patient Problem Reaction (2414)

Event Date 04/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog # 114991, discovery xs condyle kit with align, lot # 582220, unknown discovery ulnar component.Foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001825034-2018-03779.

Event Description

It was reported that a patient underwent an initial total elbow arthroplasty.Subsequently, the patient was revised due to metallosis and humeral loosening.Currently there is no further information available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Examination of the returned complaint product as well as provided patient x-rays confirms loosening with damage/wear.Review of device history records found these units were released to distribution with no related deviations or anomalies.Per the x-ray review: "large geographic zones of periprosthetic lucency and aneurysmal dilatation of the bone in the humerus component (slightly less severe on the right column) and eccentric positioning of the ulnar component within the diaphysis.Findings are nonspecific but can be seen with metallosis or particle disease." 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 HUMERAL 3.5X84MM RIGHT FLANGE
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7569070
• MDR Text Key: 110067557
• Report Number: 0001825034-2018-03780
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: PK090473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: CP561030
• Device Lot Number: 642380
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention