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U.S. Department of Health and Human Services

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

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ZIMMER, INC. UNKNOWN CUP PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Unstable (1667)
Patient Problem Complaint, Ill-Defined (2331)
Event Type  Injury  
Manufacturer Narrative
(b)(4). It is unknown if product is being returned to zimmer biomet for investigation. 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: 0001822565-2017-02259, 0001822565-2017-02260, 0001822565-2017-02263.
 
Event Description
It was reported patient underwent a total hip arthroplasty on an unknown date and was revised due to instability. Attempts to obtain additional information have been made; however, no more is available.
 
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Brand NameUNKNOWN CUP
Type of DevicePROSTHESIS, 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 Key6494088
MDR Text Key72838578
Report Number0001822565-2017-02264
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2017
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: 04/14/2017 Patient Sequence Number: 1
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