MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HUMERAL STEM; ELBOW, PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Unspecified Infection (1930); Sepsis (2067)

Event Date 11/03/2017

Event Type  Death  

Manufacturer Narrative

(b)(4) date of death - unknown date approximately seven years post-initial total elbow arthroplasty.Concomitant medical products: unknown, unknown ulnar stem, unknown.(b)(6).Report source, literature - ernstbrunner, l.Et al (2018).Long-term results of total elbow arthroplasty in patients with hemophilia.Journal of shoulder and elbow surgery, 27(1), 126-132.Doi: 10.1016/j.Jse.2017.09.009.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-01002, 0001822565-2018-01016, 0001822565-2018-01017.

Event Description

It was reported in a journal article that one patient developed a late periprosthetic infection in a previously implanted unknown knee after a joint bleed.The periprosthetic infection further became complicated into the patient's bilateral implanted elbows.Due to periprosthetic infection, with the identified primary source of the knee, the polyethylene and pins were exchanged in the total elbow systems.The patient subsequently died of sepsis seven years after the initial bilateral total elbow arthroplasty.No further information has been provided concerning the reported event.

• Brand Name: UNKNOWN HUMERAL STEM
• Type of Device: ELBOW, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7290235
• MDR Text Key: 100727832
• Report Number: 0001822565-2018-01001
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death; Hospitalization; Required Intervention