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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 Difficult or Delayed Separation (4044)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: item #: unknown unknown head lot #: unknown, item #: unknown unknown stem lot #: unknown, item #: unknown unknown cup lot #: unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. 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 - 2019 - 05792 cup, 0001825034 - 2019 - 05815 stem.
 
Event Description
It was reported that a patient underwent a hip arthroplasty on an unknown date. Subsequently the patient was revised due to aseptic loosening. Taper was stuck to stem. Attempts were made to obtain additional information; however, none was available.
 
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Brand NameUNKNOWN STEM
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 Key9535502
MDR Text Key173294441
Report Number0001825034-2019-05815
Device Sequence Number1
Product Code MEH
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
Type of Report Initial,Followup
Report Date 01/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN STEM
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/31/2019 Patient Sequence Number: 1
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