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U.S. Department of Health and Human Services

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

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ZIMMER, INC. UNKNOWN STEM HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Bone Fracture(s) (1870)
Event Date 08/20/2011
Event Type  Injury  
Manufacturer Narrative
(b)(4). Follow up report updated following information: concomitant medical products: unknown cup catalog #: ni lot#: ni, unknown liner catalog #: ni lot#: ni, unknown head catalog #: ni lot#: ni. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-05223, 0001822565-2017-05222. Reported event was unable to be confirmed due to limited information received from the customer. 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 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 was reported that patient was revised due to subluxation and non-union of perprosthetic trochanteric fracture. Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
(b)(4). Current information is insufficient to permit a conclusion to the cause of the event.
 
Event Description
It was reported that patient underwent a hip revision due to periprosthetic trochanteric fracture.
 
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Brand NameUNKNOWN STEM
Type of DeviceHIP PROSTHESIS
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 Key6414858
MDR Text Key110125785
Report Number0001822565-2017-01778
Device Sequence Number1
Product Code MEH
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2017
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 Received07/27/2017
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: 03/17/2017 Patient Sequence Number: 1
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