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

Device Problems Migration or Expulsion of Device (1395); Metal Shedding Debris (1804); Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Reaction (2414); No Information (3190)

Event Date 03/09/2015

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

It is reported that the patient underwent elbow arthroplasty revision due to unknown reasons.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.No device or photos were received; therefore the condition of the device is unknown.Device history records cannot be reviewed since the lot number is unknown.This device is used for treatment.Product history search cannot be completed since the lot number is unknown.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definite root cause cannot be determined with the information provided.

Manufacturer Narrative

This follow-up report is being filed to correct information.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It is reported that the patient underwent elbow arthroplasty revision due to unknown reasons.Further information received in patient medical records report patient began experiencing elbow difficulties approximately seventeen years post-implantation, and subsequently underwent an elbow arthroplasty revision approximately eighteen years post-implantation due to ulnar component loosening, poly bushing wear, pain, and stiffness.Metallosis was also noted in the revision operative notes.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was confirmed through receipt of operative notes.Revision operative notes report that, "ulna component was loose with wear of the polyethylene bushing.An extra small coonrad morrey ulna component was cemented in with new bushing." a definitive root cause was unable to be determined.

• Brand Name: UNKNOWN COONRAD-MORREY ULNAR COMPONENT
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6144609
• MDR Text Key: 61433635
• Report Number: 0001822565-2016-04534
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 82