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

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM PROSTHESIS, HIP

  • 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 BIOMET, INC. UNKNOWN STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Cardiac Arrest (1762)
Event Type  Death  
Manufacturer Narrative
(b)(4) upon receipt of information received and reassessment of the reported event, it was determined to be not reportable. The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
(b)(4). Multiple mdr's were submitted for this event. Please see reports: 0001825034 - 2017 - 08920. 0001825034 - 2017 - 08921. 0001825034 - 2017 - 08922. 0001825034 - 2017 - 08923. Concomitant products: femoral head,unknown part/lot, acetabular liner, unknown part/lot, femoral stem,unknown part/lot, acetabular cup, unknown part/lot. Report source : foreign. The event(s) occurred in (b)(6). ¿surgical delay as a risk factor for wound infection after a hip fracture. ¿ injury, elsevier, 28 sept. 2016, www. Sciencedirect. Com/science/article/pii/s0020138316306076. 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. Root cause was unable to be determined. 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
Fifteen 15 cases of cardiac failure as a mortality medical complication were reported in the study. No further information has been made available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN STEM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6961584
MDR Text Key105946961
Report Number0001825034-2017-08923
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Other Device ID NumberN/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 Received10/25/2017
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 NumberN/A

Patient Treatment Data
Date Received: 10/19/2017 Patient Sequence Number: 1
Treatment
SEE H10 NARRATIVE
-
-