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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Loss of Range of Motion (2032); Peritonitis (2252)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Concomitant: unknown, unknown ulnar component, unknown.(b)(6).Report source, literature: lami, d., chivot, m., caubere, a., galland, a., argenson, j.N.(2017).First-line management of distal humerus fracture by total elbow arthroplasty in geriatric traumatology: results in a 21-patient series at a minimum 2 years¿ follow-up.Orthopaedics & traumatology: surgery & research, 103(6), 891-897.Doi: 10.1016/j.Otsr.2017.06.009.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 - 01083.Product location unknown.

Event Description

It was reported in a journal article that a patient developed peritonitis eighteen days post-operatively which required a thirty-two day admission to the visceral surgery department which resulted in asthenia, involved extreme immobilization, and stiffness.The patient declined a revision for release of prosthetic joint and was unable to restore to a functional range of motion after rehabilitation therapy.It is believed this post-operative complication was the reason for stiffness.Patient was dissatisfied with the surgery.No further information has been provided.

• Brand Name: UNKNOWN HUMERAL COMPONENT
• Type of Device: PROSTHESIS, ELBOW
• 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: 7292350
• MDR Text Key: 100798245
• Report Number: 0001822565-2018-01082
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• 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): Hospitalization; Other