MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISCOVERY XS LEFT HUMERAL 3.5X124MM FLANGED; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Migration (4003)

Patient Problems Pain (1994); Reaction (2414)

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 114991, lot #: 318950, disc xs condyle kit w align; catalog : ni, lot #: ni , 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 -08642.

Event Description

It was reported that a patient underwent a discovery total elbow replacement.Subsequently, the patient underwent a revision approximately four (4) years post-implantation due to pain, metallosis, and loosening of the humeral component.No additional information is currently available.

Manufacturer Narrative

(b)(4).Examination of the returned product confirms loosening.No bony ingrowth or bone cement is observed on the porous surface of the humeral component.The humeral flange and condyle kit were installed together.The screws are in place holding the condyles onto the humeral flange.There is some wear on the condyles.The screws holding the condyle to the flange are slightly loose allowing the condyles to move which could cause an event of metallosis; however, this is unconfirmed.Review of device history records did not identify any related manufacturing deviations or anomalies that would have contributed to the reported event.Root cause is undetermined.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.

Event Description

No further information.

• Brand Name: DISCOVERY XS LEFT HUMERAL 3.5X124MM FLANGED
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7834514
• MDR Text Key: 118866734
• Report Number: 0001825034-2018-08643
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• 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: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: CP561031
• Device Lot Number: 983270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2018
• 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
• Patient Age: 74 YR