MAUDE Adverse Event Report: ZIMMER, INC. COONRAD/MORREY PIN/B USHING REPLACEMENT KIT; ELBOW PROSTHESIS

Catalog Number 32810502501

Device Problems Fracture (1260); Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Osteolysis (2377); No Information (3190)

Event Date 11/11/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient has a planned revision surgery to revise the bearing.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

It is now known that the patient underwent elbow arthroplasty revision due to osteolysis around the humeral component and wear and breakage of the polyethylene bushings.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Subcomponent items were received for evaluation and the dimensions able to be taken were within specification.It was found that the ulna and humeral bushing show severe damage.Inner pin contains debris and outer pin shows wear.The device history records cannot be reviewed since the lot number is unknown.This device is used for treatment.Surgical technique and notes were not provided.It was noted that osteolysis was found around the humeral component however a definitive root cause of the reported issue cannot be determined with the information provided.

Event Description

It was reported that patient underwent an elbow arthroplasty revision approximately fourteen years post-implantation due to bushing wear and fracture, and osteolysis around the humeral component.The bushings were removed and replaced.

• Brand Name: COONRAD/MORREY PIN/B USHING REPLACEMENT KIT
• Type of Device: ELBOW PROSTHESIS
• 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: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6096608
• MDR Text Key: 59715745
• Report Number: 0001822565-2016-04180
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 32810502501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 75