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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN LINER PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Noise, Audible (3273)
Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544)
Event Date 03/01/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown, unknown head, unknown, unknown, unknown cup, unknown, unknown, unknown stem, unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 01709. Remains implanted.
 
Event Description
It was reported that the implant popped and has been making a cruching sound since installation. The patient is also experiencing pain, swelling, and difficulty standing for a long time. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NameUNKNOWN LINER
Type of DevicePROSTHESIS, 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 Key7348352
MDR Text Key102726845
Report Number0001825034-2018-01708
Device Sequence Number1
Product Code LZO
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 consumer,other
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 08/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2018
Was Device Evaluated by Manufacturer? No
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: 03/19/2018 Patient Sequence Number: 1
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