MAUDE Adverse Event Report: ZIMMER, INC. COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY EXTRA SMALL; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Fracture (1260); Unstable (1667)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Fracture, Arm (2351); Osteolysis (2377)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product - compact vacuum cement mixing system, cat#:00504903, lot#: 61949805.Customer has indicated that the product will not be returned [as location is unknown] 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: 0001822565-2017-03207.

Event Description

It was reported that the patient underwent a left elbow arthroplasty revision approximately 5 years post-implantation due to elbow pain/swelling with instability, clicking, and limited range of motion.Physician office notes and radiographs received note peri-prosthetic fracture and fracture of the humeral component, with osteolysis around the ulnar and humeral implant.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.It is noted in imaging/test results portion of the medical records that "there is a transverse fracture of the humeral prosthesis.This occurred at the interface between the humeral canal and where the bone ends.There is some osteolysis around both the ulnar implant of the humeral implant.There is cement well up into the canal of the humerus." device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.It is noted in medical records that the patient "has a demented husband who requires a lot of care.She has been lifting him at night with her only good arm which is her left arm." it is stated in the instructions for use, "note: the prosthesis will not restore function to the level expected with a normal healthy joint, and has functional limitations.Excessive muscular activity, e.G., pounding, carrying loads must be avoided or restricted.The patient must not lift more than one pound during the first three postoperative months and not more than five pounds with the operated arm.In addition, the risks and complications listed under adverse effects must be explained to and discussed with the patient." root cause is determined to be related to the patient not following postoperative restrictions.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: COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY EXTRA SMALL
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6560109
• MDR Text Key: 74929392
• Report Number: 0001822565-2017-03206
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK001989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 32810502704
• Device Lot Number: 61883946
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2011
• 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: 57 YR
• Patient Weight: 88