• 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. HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM LENGTH 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. HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM LENGTH PROSTHESIS ELBOW Back to Search Results
Model Number N/A
Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); 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
This follow-up report is being submitted to relay additional information. (b)(4). Concomitant medical product: nexel total elbow ulnar component, catalog#: 00840002407, lot#: 63040257. Articulation kit, catalog#: 00840009400, lot#: 63085698. Humeral screw kit, catalog#: 00840009000, lot#: 63139663. Cemex bone cement, catalog#: ni, lot#: ni. 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.
 
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
(b)(4). Medical product - humeral screw kit 2 humeral screws, catalog # 00840009000, lot # 63139663. This investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
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 NameHUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM LENGTH
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 Key6776349
MDR Text Key114481133
Report Number0001822565-2017-05231
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/22/2017
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 Number00840004410
Device Lot Number63050690
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 Received09/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2015
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
-
-