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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN HEAD PROSTHESIS, HEAD

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ZIMMER, INC. UNKNOWN HEAD PROSTHESIS, HEAD Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 07/13/2017
Event Type  Injury  
Manufacturer Narrative
(b)(6). Concomitant medical products: unk, unknown liner, unk; unk, unknown cup, unk; unk, unknown stem, unk. (b)(4). Report source, literature - mcgrory, b. Et al (2017). High early major complication rate after revision for mechanically assisted crevice corrosion in metal-on-polyethylene total hip arthroplasty. The journal of arthroplasty, 1-7. Doi: 10. 1016/j. Arth. 2017. 07. 004. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 05805; 0001822565 - 2017 - 05806; 0001822565 - 2017 - 05807. - (b)(4).
 
Event Description
It has been reported in a journal article that 31 patients were revised for unknown reasons. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NameUNKNOWN HEAD
Type of DevicePROSTHESIS, HEAD
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 Key6795111
MDR Text Key82753396
Report Number0001822565-2017-05804
Device Sequence Number1
Product Code LZY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 08/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2017
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: 08/15/2017 Patient Sequence Number: 1
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