• 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 TOTAL ELBOW ULNAR COMPONENT 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 TOTAL ELBOW ULNAR COMPONENT PROSTHESIS ELBOW Back to Search Results
Model Number N/A
Device Problems Loose or Intermittent Connection (1371); Unstable (1667)
Patient Problems Pain (1994); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Information (3190)
Event Date 06/01/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical product: nexel total elbow humeral component, catalog#: 00840004410, lot#: 63050690; articulation kit, catalog#: 00840009400, lot#: 63085698; humeral screw kit, catalog#: 00840009000, lot#: 63139663; cemex bone cement, catalog#: ni, lot#: ni.
 
Event Description
It is reported that patient experienced pain, instability, severe right humeral component loosening and subsidence approximately 14 months post-implantation. Patient also exhibited ulnar and humeral osteolysis. Patient was treated by aspiration of approximately 15 cc from the operative elbow. Outcome is pending.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of medical records provided. No x-rays were provided. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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
(b)(4). Concomitant medical product - humeral component plasma sprayed size 4 100 mm length, catalog # 00840004410, lot # 63050690. This investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 0001822565 - 2017 - 05231.
 
Event Description
It was reported that a patient's humeral components shows signs of loosening. An aspiration was performed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEXEL TOTAL ELBOW ULNAR COMPONENT
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 Key6778247
MDR Text Key113286312
Report Number0001822565-2017-05543
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00840002407
Device Lot Number63040257
Other Device ID NumberSEE H10 NARRATIVE
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 Received10/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2015
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: 08/09/2017 Patient Sequence Number: 1
-
-