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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Malposition of Device (2616)
Patient Problem No Information (3190)
Event Date 01/08/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Concomitant medical products: item #: unknown head lot #: unknown, item #: unknown liner lot #: unknown, item #: unknown cup lot #: unknown.Reported event was confirmed by review of radiographs.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
It was reported that patient underwent an initial right total hip arthroplasty.During the procedure a broach with an 11 with a minus 3 was used, the surgeon went down to a real 10 and a minus 6.Surgeon is not happy this did not fix his length issues.The stem sat proud slightly.Attempts were made to obtain additional information; however, none was available.
 
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Brand Name
UNKNOWN STEM
Type of Device
PROSTHESIS, 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 Key9876818
MDR Text Key188861406
Report Number0001825034-2020-01133
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/13/2020
Initial Date FDA Received03/25/2020
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
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