MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DISCOVERY ELBOW SYSTEM EXTRA SMALL FLANGED HUMERAL LEFT; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem Reaction (2414)

Event Date 04/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product-disc xs condyle kit w align, catalog#: 114991, lot#: 665670.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 reports: 0001825034-2017-03356.

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.

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.

• Brand Name: DISCOVERY ELBOW SYSTEM EXTRA SMALL FLANGED HUMERAL LEFT
• 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: 6578083
• MDR Text Key: 75536374
• Report Number: 0001825034-2017-03357
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 114912
• Device Lot Number: 510780
• Other Device ID Number: REFERENCE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• 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: 67 YR