• 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. UNKNOWN LONGEVITY HIGHLY CROSS-LINKED POLYETHYLENE LINER; 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, INC. UNKNOWN LONGEVITY HIGHLY CROSS-LINKED POLYETHYLENE LINER; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Thrombosis (2100)
Event Date 04/05/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant products: unknown trilogy modular trabecular metal shell, unknown femoral head, unknown versys fully porous-coated femoral stem; therapy date unknown.Abdel, m.P., chalmers, b.P., trousdale, r.T., hanssen, a.D., and pagnano, m.W.(2017).Randomized clinical trial of 2-incision vs mini-posterior total hip arthroplasty: differences persist at 10 years.The journal of arthroplasty.Doi:10.1016/j.Arth.2017.04.005.No devices or photos of the devices were received; therefore, the condition of the components is unknown.Additionally, visual and dimensional evaluations could not be performed.The product number and the lot number were not provided; therefore, the manufacturing date, the device history records and the field age of the device could not be determined.There is insufficient information to perform a complaint history search.A definitive root cause could not 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-03715, 0001822565-2017-03716, 0001822565-2017-03717.
 
Event Description
It was reported in a journal article that one patient experienced an acute deep venous thrombosis.The patient was treated with anticoagulation medication and there was no long term sequelae.No other patient consequences were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN LONGEVITY HIGHLY CROSS-LINKED POLYETHYLENE LINER
Type of Device
PROSTHESIS, HIP
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 Key6603091
MDR Text Key76369304
Report Number0001822565-2017-03718
Device Sequence Number1
Product Code JDG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation Physician
Type of Report Initial
Report Date 05/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/15/2017
Initial Date FDA Received05/31/2017
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 Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
-
-