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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Roskidaylo et al. "total elbow replacement coonrad-morrey in patients with rheumatoid arthritis. " orthopaedic, fsbi research institute of rheumatology. 72:a892. 3-a892. Date implanted - post-operative x-rays indicate that the devices were implanted on or prior to (b)(6) 2012. Initial reporter - the article was written by a roskidaylo, a logunov, s makarov and v amirdjanova. Device evaluated by manufacturer - the device has been requested for return, but no response was received from the journal article author that indicates that product will be returned.

Event Description

It is reported in a journal article that one patient underwent left elbow arthroplasty revision due to loosening of the ulnar component two years following elbow arthroplasty secondary to incorrect implantation. Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

The complaint sample was reviewed through an x-ray review and the reported event was confirmed. An x-ray review confirmed that, "earlier x-rays show loosening of the ulnar component with ulnar stem malpositioned in varus alignment, and with the distal stem breaching the posterior lateral cortex of the ulna surrounded by chronic periosteal new bone surrounding the distal stem. A later x-ray shows distal migration/loosening of the humeral component. Later x-rays also show revision of the ulnar component, with the new ulnar stem breaching the lateral cortex of the ulna distally and apparent loosening of the ulnar component. " it was further noted, "bones appear osteopenic, possibly contributing to migration/loosening of the ulnar component". A device history record review was unable to be performed as the lot number of the device involved in the event is unknown. A review of the complaint history was unable to be performed as the part and lot number is unknown. Investigation results concluded that the reported event was due to incorrect implantation of the ulnar component, as previously reported by the author of the journal article.

• Brand Name: UNKNOWN COONRAD-MORREY ULNAR COMPONENT
• 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: 6417935
• MDR Text Key: 70362536
• Report Number: 0001822565-2017-01733
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/12/2017
• 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 Treatment Data

Date Received: 03/20/2017 Patient Sequence Number: 1