MAUDE Adverse Event Report: ZIMMER, INC. COONRAD/MORREY SMALL ULNAR ASSEMBLY PROSTHESIS, ELBOW

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 04/14/2017

Event Type  Injury  

Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Radiographic evaluation of the lateral view of the right elbow does not confirm or exclude the reported event. Evaluation for polyethylene wear of bushings and hinge failure cannot be made due to lack of ap x-ray view. 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. 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.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event. Concomitant devices - coonrad/morrey small humeral assembly catalog #: 32810500400 lot #: 34469800, howmedica simplex cement catalog #: 6191-1-001 lot #: rkc 090. The customer has indicated that the device will not be returned to zimmer biomet for evaluation, as the device was discarded. The investigation is in process. Once the investigation is completed, a follow-up mdr will be submitted. This report is number 1 of 2 mdrs filed for the same patient (reference 0001822565-2017-03150).

Event Description

It is reported that the patient underwent an elbow arthroplasty revision due to wear twenty-one (21) years following implantation. Only the bushings and hinge pin were exchanged utilizing ulnar and humeral replacement kits while leaving the implants themselves in the patient. No further patient consequences were reported.

• Brand Name: COONRAD/MORREY SMALL ULNAR ASSEMBLY
• 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: 6556720
• MDR Text Key: 109402439
• Report Number: 0001822565-2017-03149
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK883665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 32810500200
• Device Lot Number: 34470400
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/1995
• 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 Treatment Data

Date Received: 05/10/2017 Patient Sequence Number: 1

Treatment

SEE H10 NARRATIVE; SEE H10 NARRATIVE