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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Roskidaylo et al."total elbow replacement coonrad-morrey in patients with rheumatoid arthritis." orthopaedic, fsbi research institute of rheumatology.72:a892.3-a892.Please reference attached journal article.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Date implanted - x-rays taken pre-operatively and post-operatively indicate that the patient was implanted between (b)(6) 2011 and (b)(6) 2012.Initial reporter - the article was written by a roskidaylo, a logunov, s makarov and v amirdjanova.

Event Description

It is reported in a journal article that one patient experienced elbow stiffness following elbow arthroplasty.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample x-rays were evaluated and the reported event was not confirmed.X-rays of the elbow show coonrad/morrey total arthroplasty components in place.Skin staples are present posteriorly suggesting these x-rays were obtained in the postoperative time period.There is no evidence of loosening of the humeral component.There is a focal radiolucency within the ulnar shaft, at and distal to the tip of the ulnar component stem which raises a suspicion of proximal migration of the ulnar component.On the lateral flexion view of the elbow, the coronoid process contacts the anterior humeral flange.The ulnar component may have been seated too deeply, resulting in restricted flexion with coronoid process contacting humeral flange and impingement pistoning of the ulnar stem with elbow flexion.A metal pin projects over the medial epicondyle, possibly due to disassociation of the hinge pin versus intentional pin fixation of the medial epicondyle.None of the images submitted are true ap views, cannot exclude valgus angulation of the ulnar stem component on the oblique views.If the ulnar component is truly in valgus, this would also indicate a failure of the hinge or bushing components.Root cause remains undetermined.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 ELBOW IMPLANT
• 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: 6473439
• MDR Text Key: 72174142
• Report Number: 0001822565-2017-02000
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2017
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other