• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. NEXEL PLASMA SPRAYED ULNAR COMPONENT SIZE 6 115MM LENGTH LEFT PROSTHESIS, ELBOW

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER, INC. NEXEL PLASMA SPRAYED ULNAR COMPONENT SIZE 6 115MM LENGTH LEFT PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problems Difficult To Position (1467); Inadequacy of Device Shape and/or Size (1583)
Patient Problem Perforation (2001)
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. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. 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
(b)(4). The customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. This report is number 2 of 2 mdrs filed for the same patient (reference 0001822565-2017-04349).
 
Event Description
It was reported that during left elbow arthroplasty, the long ulnar component didn¿t fit into the medullary cavity and punctured the patient¿s ulna. The surgeon attempted to bend the ulnar component, but alternatively decided to use a shorter ulnar component to complete the procedure. No additional patient consequences were reported. Attempts have been made to retrieve additional information, but no further information is available at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEXEL PLASMA SPRAYED ULNAR COMPONENT SIZE 6 115MM LENGTH LEFT
Type of DevicePROSTHESIS, 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 Key6657933
MDR Text Key110214457
Report Number0001822565-2017-04348
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
PK123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00840001611
Other Device ID NumberN/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 Received07/28/2017
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
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/21/2017 Patient Sequence Number: 1
-
-