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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: unknown, unknown ulnar component, unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001822565 - 2017 - 08618.

Event Description

It was reported that the patient underwent an initial right elbow arthroplasty on an unknown date.Subsequently, the patient has been indicated for a revision due to unknown reasons.No further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Additional: updated.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Date of event - unknown date in (b)(6) 2017.Date of implant - unknown date in 2007.Date of explant - unknown date in (b)(6) 2017.

Event Description

It was reported that the patient underwent an initial right elbow arthroplasty and was revised due to loosening of the humeral prosthesis.No further information has been provided.

Manufacturer Narrative

Reported event was confirmed by review of x-rays provided and notes provided by rep.X-ray reviewer stated "significant radiolucency is identified at the bone cement interface of all of the images of the humeral component which progresses until fracture of the humerus.Some radiolucency is also identified at the bone cement interface of the ulnar component.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 as the necessary information to adequately investigate the reported event was not provided.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: UNKNOWN COONRAD MORREY 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: 7160526
• MDR Text Key: 96325037
• Report Number: 0001822565-2017-08617
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 03/14/2018
• 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; Required Intervention
• Patient Weight: 70